Cleared Traditional

DISPOSABLE, MANUAL PULMONARY RESUSCITATOR

K873286 · Hospitak, Inc. · Anesthesiology
Oct 1987
Decision
70d
Days
Class 2
Risk

About This 510(k) Submission

K873286 is an FDA 510(k) clearance for the DISPOSABLE, MANUAL PULMONARY RESUSCITATOR, a Ventilator, Emergency, Manual (resuscitator) (Class II — Special Controls, product code BTM), submitted by Hospitak, Inc. (Lindenhurst, US). The FDA issued a Cleared decision on October 26, 1987, 70 days after receiving the submission on August 17, 1987. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5915.

Submission Details

510(k) Number K873286 FDA.gov
FDA Decision Cleared SESE
Date Received August 17, 1987
Decision Date October 26, 1987
Days to Decision 70 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BTM — Ventilator, Emergency, Manual (resuscitator)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5915

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