Cleared Traditional

CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT

K936182 · Ohmeda Medical · Cardiovascular
Mar 1994
Decision
88d
Days
Class 2
Risk

About This 510(k) Submission

K936182 is an FDA 510(k) clearance for the CRITIKIT PLUS IN LINE ROOM/ICE TEMPERATURE INJECTATE KIT, a Probe, Thermodilution (Class II — Special Controls, product code KRB), submitted by Ohmeda Medical (Oxnard, US). The FDA issued a Cleared decision on March 25, 1994, 88 days after receiving the submission on December 27, 1993. This device falls under the Cardiovascular review panel. Regulated under 21 CFR 870.1915.

Submission Details

510(k) Number K936182 FDA.gov
FDA Decision Cleared SESE
Date Received December 27, 1993
Decision Date March 25, 1994
Days to Decision 88 days
Submission Type Traditional
Review Panel Cardiovascular (CV)
Summary Statement

Device Classification

Product Code KRB — Probe, Thermodilution
Device Class Class II — Special Controls
CFR Regulation 21 CFR 870.1915

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