TISSUE OXYGEN MONITOR SYSTEM, MODEL II— 510(k) K890624

Name: FDA 510(k) clearance K890624
Creator: U.S. Food and Drug Administration
Published: 1989-12-22

Substantially Equivalent

Baxter Healthcare Corp

FDA 510(k) clearance K890624 for TISSUE OXYGEN MONITOR SYSTEM, MODEL II, Substantially Equivalent on 1989-12-22. Applicant: Baxter Healthcare Corp. Device class: 2.

Clearance details

Applicant: Baxter Healthcare Corp
Product code: Code CCE
Device class: Class 2
Regulation: 21 CFR 868.1200
Advisory panel: Anesthesiology
Date received: 1989-02-07
Decision date: 1989-12-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Santa Ana, CA, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code CCE

view all

K935778 — VIA 1-01 INFUSION PUMP/BLOOD CHEMISTRY SYSTEM1996-12-05
K912145 — SYSTEM ATHENA-PRODUCT ENHANCEMENTS, ANESTHESIA1992-05-05
K910453 — TOPS NEEDLE TIP PROBE & PVC TIP PROBE1991-08-13
K905397 — PB3200 INTRA-ARTERIAL BLOOD GAS MONITORING SYSTEM1991-05-14
K896311 — OPTEX BLOOD GAS MONITORING SYSTEM1990-01-03

More clearances from Baxter Healthcare Corp

view all

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