Mortara Instrument, Inc.
Mortara Instrument, Inc. holds FDA 510(k) medical device clearances, first cleared 1983, most recent 2019, with 2 FDA device recalls on record.
Top product codes for Mortara Instrument, Inc.
FDA recalls by Mortara Instrument, Inc.
- Z-1796-2015 — ELI 380 Electrocardiograph. The ELI 380 is intended to be a high-performance, multichannel resting electrocardiograph. As a resting electrocardiograph, the ELI 380 simultaneously acquires data from each lead. Once the data is acquired, it can be analyzed, reviewed, stored, printed or transmitted. It is a device primarily intended for use in hospitals, but may be used in medical clinics and offices of any size.
- Z-0110-2015 — Mortara Surveyor S12 and Surveyor S19 Patient Monitors. Product Usage: They are indicated for use in adult & pediatric patient populations. They facilitate the monitoring of: Non-invasive blood pressure (NIBP), Impedance respiration, Invasive blood pressure (P1-P4), Temperature, Functional arterial oxygen saturation (SpO2), End-tidal & inspired CO2, ECG monitoring with arrhythmia and ST-segment analysis, 12-Lead resting ECG, Cardiac output (C)). The Mortara Surveyor Patient Monitor is a prescription device intended to be used by healthcare professionals in all areas of a healthcare facility.
Recalls are matched by FDA's recalling-firm name — openFDA's enforcement dataset doesn't reference 510(k) numbers, so a recall here may cover devices beyond this company's 510(k) clearances.
Recent clearances by Mortara Instrument, Inc.
- K182297 — Surveyor S2
- K173765 — Surveyor Patient Monitor
- K161517 — Mortara Surveyor Patient Monitor
- K161465 — CardioConfirm
- K160685 — Surveyor S4 Mobile Monitor
- K152626 — H3+ Holter Recorder
- K152944 — Xscribe Stress Exercise Testing Systems, Q-Stress Stress Exercise Testing Systems
- K141020 — SURVEYOR S4 MOBILE MONITOR
- K133989 — AMBULO 2400 AMBULATORY BLOOD PRESSURE MONITORING SYSTEM
- K141811 — MORTARA MONITORING WAVEFORM VIEWER
- K142105 — ELI 380 ELECTROCARDIOGRAPH
- K131929 — SURVEYOR CENTRAL STATION
- K123556 — MORTARA SURVEYOR PATIENT MONITOR
- K122073 — ELI 280 ELECTROCARDIOGRAPH
- K120865 — RSCRIBE ELECTROCARDIOGRAPH
- K102206 — ELI 10 ELECTROCARDIOGRAPH MODEL ELI 10
- K101403 — ELI 250 ELECTROCARDIOGRAPH
- K101115 — ELI 150 ELECTROCARDIOGRAPH MODEL ELI 150
- K100127 — ELI 230 ELECTROCARDIOGRAPH
- K093339 — ELI PC ELECTROCARDIOGRAPH
- K092663 — ELI 350 ELECTROCARDIOGRAPH
- K082946 — MORTARA ELI 350 ELECTROCARDIOGRAPH
- K081800 — T12S TELEMETRY TRANSMITTER
- K070539 — MORTARA ELI 10 ELECTROCARDIOGRAPH
- K062677 — ELI 350 ELECTROCARDIOGRAPH
- K060135 — MORTARA SURVEYOR TELEMETRY CENTRAL STATION
- K050896 — H12+ HOLTER RECORDER
- K043010 — HOLTER RECORDER H3+
- K031182 — ELI 200+ AUDICOR
- K022618 — X-SCRIBE II
- K021373 — H12+HOLTER RECORDER
- K004017 — H-SCRIBE
- K974149 — AMBULATORY X-12 TELEMETRY MODULE
- K942685 — ECG REVIEW STATION
- K933143 — MODEL ELI 300 ELECTROCARDIOGRAPH
- K930558 — MORTARA INSTRUMENT, INC. E-SCRIBE
- K915730 — MORTARA INSTRUMENT ODEL ELI 50I
- K922927 — MORTARA INSTRUMENT ST CENTRAL STATION
- K920626 — MODEL ELI 200 ELECTROCARDIOGRAPH
- K920627 — MODEL ELI 100 ELECTROCARDIOGRAPH
- K920377 — MORTARA INSTRUMENT MODEL ECG PREVU
- K911097 — PR4
- K900720 — MORTARA INSTRUMENT MODEL X-SCRIBE (TREADMILL INCLUDED)
- K902652 — MORTARA INSTRUMENT MODEL ELI 50
- K895232 — MODEL ELI-100/ST ELECTROCARDIOGRAPH
- K880664 — MORTARA INSTRUMENT MODEL ELI-XR (TREADMILL INCLUDED)
- K864580 — MODEL EL-1 W/ST MONITOR OPTION (ACRONYM = ELI/STM)
- K861850 — BURDICK DIVISION (E-500)
- K861851 — SIEMENS-ELEMA (SICARD-P)
- K851702 — MORTARA INSTRUMENT MODEL EL-1
- K832050 — MORTARA INSTRUMENT #101
Data sourced from openFDA. This site is unofficial and independent of the FDA.