HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR— 510(k) K874605

Name: FDA 510(k) clearance K874605
Creator: U.S. Food and Drug Administration
Published: 1988-02-02

Substantially Equivalent

Mallinckrodt Critical Care

FDA 510(k) clearance K874605 for HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR, Substantially Equivalent on 1988-02-02. Applicant: Mallinckrodt Critical Care. Device class: 1.

Clearance details

Applicant: Mallinckrodt Critical Care
Product code: Code KRI
Device class: Class 1
Regulation: 21 CFR 870.4200
Advisory panel: Cardiovascular
Date received: 1987-11-09
Decision date: 1988-02-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Argyle, NY, US

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More clearances from Mallinckrodt Critical Care

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K880343 — BURNEY GALLBLADDER CATHETER KIT1989-05-01
K874514 — HI-LO TEMP(R) GENERAL PURPOSE TEMPERATURE PROBE1988-01-29
K874568 — HI-LO TEMP(R) MODEL 8700 PATIENT TEMP MONITOR1988-01-06
K873461 — LASER-FLEX(TM) TRACHEAL TUBE (CUFFED)1987-11-06
K874404 — HI-LO TEMP(R) SKIN TEMPERATURE SENSOR1987-11-06

Data sourced from openFDA. This site is unofficial and independent of the FDA.