RESCUE BREATHER— 510(k) K955520

Substantially Equivalent

International Safety, Inc.

FDA 510(k) clearance K955520 for RESCUE BREATHER, Substantially Equivalent on 1996-10-08. Applicant: International Safety, Inc.. Device class: 2.

Clearance details

Applicant: International Safety, Inc.
Product code: Code CBP
Device class: Class 2
Regulation: 21 CFR 868.5870
Advisory panel: Anesthesiology
Date received: 1995-12-04
Decision date: 1996-10-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Eugene, OR, 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.