Cleared Traditional

DISPOSABLE INCENTIVE SPIROMETER

K792598 · Hospitak, Inc. · Anesthesiology
Jan 1980
Decision
17d
Days
Class 2
Risk

About This 510(k) Submission

K792598 is an FDA 510(k) clearance for the DISPOSABLE INCENTIVE SPIROMETER, a Spirometer, Therapeutic (incentive) (Class II — Special Controls, product code BWF), submitted by Hospitak, Inc. (Mchenry, US). The FDA issued a Cleared decision on January 4, 1980, 17 days after receiving the submission on December 18, 1979. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5690.

Submission Details

510(k) Number K792598 FDA.gov
FDA Decision Cleared SESE
Date Received December 18, 1979
Decision Date January 04, 1980
Days to Decision 17 days
Submission Type Traditional
Review Panel Anesthesiology (AN)
Summary —

Device Classification

Product Code BWF — Spirometer, Therapeutic (incentive)
Device Class Class II — Special Controls
CFR Regulation 21 CFR 868.5690