RESCUE BREATHER— 510(k) K940927

Substantially Equivalent

O-Two Systems Intl., Inc.

FDA 510(k) clearance K940927 for RESCUE BREATHER, Substantially Equivalent on 1994-10-14. Applicant: O-Two Systems Intl., Inc.. Device class: 2.

Clearance details

Applicant: O-Two Systems Intl., Inc.
Product code: Code CBP
Device class: Class 2
Regulation: 21 CFR 868.5870
Advisory panel: Anesthesiology
Date received: 1994-02-28
Decision date: 1994-10-14
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mississauga, CA

Download summary PDF View on FDA.gov ↗

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