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

Name: FDA 510(k) clearance K903489
Creator: U.S. Food and Drug Administration
Published: 1990-12-10

Substantially Equivalent

Pegasus Research Corp.

FDA 510(k) clearance K903489 for THERA-MIST TM VOLUMINA INCENT SPIROMETER, P40000, Substantially Equivalent on 1990-12-10. Applicant: Pegasus Research Corp.. Device class: 2.

Clearance details

Applicant: Pegasus Research Corp.
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 1990-08-02
Decision date: 1990-12-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Costa Mesa, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.