Cleared Traditional

K903489 - THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000
(FDA 510(k) Clearance)

K903489 · Pegasus Research Corp. · Anesthesiology
Dec 1990
Decision
130d
Days
Class 2
Risk

K903489 is an FDA 510(k) clearance for the THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000, a Spirometer, Therapeutic (incentive) (Class II — Special Controls, product code BWF), submitted by Pegasus Research Corp. (Costa Mesa, US). The FDA issued a Cleared decision on December 10, 1990, 130 days after receiving the submission on August 2, 1990. This device falls under the Anesthesiology review panel. Regulated under 21 CFR 868.5690.

Submission Details

510(k) Number K903489 FDA.gov
FDA Decision Cleared SESE
Date Received August 02, 1990
Decision Date December 10, 1990
Days to Decision 130 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