MODIFIED CARDIOCAP MONITOR— 510(k) K862455

Clearance details

Applicant

Datex Division Instrumentarium Corp.

Product code

Code DSK

Device class

Class 2

Regulation

21 CFR 870.1110

Advisory panel

Cardiovascular

Date received

1986-06-27

Decision date

1986-09-24

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Wilmington, MA, US

• K231586 — Endophys Blood Pressure Monitor model BPM-302023-11-03
• K160945 — Endophys Blood Pressure Monitor2016-09-26
• K152582 — CORE FM System, Patient Interface Module (OPIM), Hemodynamic Converter Box2015-12-03
• K141615 — ENDOPHYS BLOOD PRESSURE MONITOR2015-01-07
• K080670 — MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEM2008-04-23

• K953175 — AS/3 ESTPR MODULE1997-02-06
• K961247 — AS/3 LIGHT MONITOR1996-10-23
• K943458 — AS/3 AIRWAY MODULE1995-02-14
• K945234 — AS/3 MEMORY MODULE, M0MEM1995-01-27
• K933156 — DATEX AS/3 PATIENT MONITOR1994-12-30