Cleared Traditional

VITAPEP

K844963 · Vitalograph , Ltd. · Anesthesiology
Jun 1985
Decision
165d
Days
Class 2
Risk

About This 510(k) Submission

K844963 is an FDA 510(k) clearance for the VITAPEP, a Spirometer, Therapeutic (incentive) (Class II — Special Controls, product code BWF), submitted by Vitalograph , Ltd. (Lenexa, US). The FDA issued a Cleared decision on June 7, 1985, 165 days after receiving the submission on December 24, 1984. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5690.

Submission Details

510(k) Number K844963 FDA.gov
FDA Decision Cleared SESE
Date Received December 24, 1984
Decision Date June 07, 1985
Days to Decision 165 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