COBE GAS FILTER— 510(k) K851289

Substantially Equivalent

Cobe Laboratories, Inc.

FDA 510(k) clearance K851289 for COBE GAS FILTER, Substantially Equivalent on 1985-06-19. Applicant: Cobe Laboratories, Inc.. Device class: 1.

Clearance details

Applicant: Cobe Laboratories, Inc.
Product code: Code KRI
Device class: Class 1
Regulation: 21 CFR 870.4200
Advisory panel: Cardiovascular
Date received: 1985-04-01
Decision date: 1985-06-19
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lakewood, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KRI

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K934782 — AMMEX TUBING ORGANIZER1993-11-18
K926233 — CARDIO2 CYCLE1993-06-04

More clearances from Cobe Laboratories, Inc.

K923272 — COBE CMS-HF HOLLOW FIBER MEMBRANE OXYGENATOR1993-05-11
K900105 — COBE SPECTRA BLOOD COMPONENT SEPARATOR THERAPEUTIC1991-03-22
K905793 — COBE CENTRY 2 BICART OPTION KIT1991-02-12
K905388 — COBE CENTRYSYSTEM 3 BICART OPTION KIT1991-02-11
K904336 — NEW COBE SATURATION/HEMATOCRIT MONITOR1990-12-27

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