HAYEK OSCILLATOR(TM)— 510(k) K924341

Substantially Equivalent

Respironics, Inc.

FDA 510(k) clearance K924341 for HAYEK OSCILLATOR(TM), Substantially Equivalent on 1993-07-21. Applicant: Respironics, Inc.. Device class: 2.

Clearance details

Applicant: Respironics, Inc.
Product code: Code BYT
Device class: Class 2
Regulation: 21 CFR 868.5935
Advisory panel: Anesthesiology
Date received: 1992-08-27
Decision date: 1993-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Murrysville, PA, 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.