Cleared Traditional

AEROSOL INHALATION MONITOR

K893665 · Vitalograph , Ltd. · Anesthesiology
Aug 1989
Decision
98d
Days
Class 2
Risk

About This 510(k) Submission

K893665 is an FDA 510(k) clearance for the AEROSOL INHALATION MONITOR, a Spirometer, Therapeutic (incentive) (Class II — Special Controls, product code BWF), submitted by Vitalograph , Ltd. (Lenexa, US). The FDA issued a Cleared decision on August 21, 1989, 98 days after receiving the submission on May 15, 1989. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5690.

Submission Details

510(k) Number K893665 FDA.gov
FDA Decision Cleared SESE
Date Received May 15, 1989
Decision Date August 21, 1989
Days to Decision 98 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