Cleared Traditional

K853396 - MULTICAP MULTIGAS CAPNOMETER PB252
(FDA 510(k) Clearance)

K853396 · Instrumentarium Corp. · Anesthesiology

Aug 1985

Decision

Days

Class 2

Risk

K853396 is an FDA 510(k) clearance for the MULTICAP MULTIGAS CAPNOMETER PB252, a Analyzer, Gas, Carbon-dioxide, Gaseous-phase (Class II — Special Controls, product code CCK), submitted by Instrumentarium Corp. (Finland, FI). The FDA issued a Cleared decision on August 16, 1985, 4 days after receiving the submission on August 12, 1985. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.1400.

Submission Details

510(k) Number	K853396 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 12, 1985
Decision Date	August 16, 1985
Days to Decision	4 days
Submission Type	Traditional
Review Panel	Anesthesiology (AN)
Summary	—