O-PEP— 510(k) K150044

Substantially Equivalent

Pari Respiratory Equipment, Inc.

FDA 510(k) clearance K150044 for O-PEP, Substantially Equivalent on 2016-05-27. Applicant: Pari Respiratory Equipment, Inc.. Device class: 2.

Clearance details

Applicant: Pari Respiratory Equipment, Inc.
Product code: Code BWF
Device class: Class 2
Regulation: 21 CFR 868.5690
Advisory panel: Anesthesiology
Date received: 2015-01-12
Decision date: 2016-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Midlothian, VA, 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.