POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A— 510(k) K042727

Name: FDA 510(k) clearance K042727
Creator: U.S. Food and Drug Administration
Published: 2005-03-18

Substantially Equivalent

Foremount Ent. Co., Ltd.

FDA 510(k) clearance K042727 for POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A, Substantially Equivalent on 2005-03-18. Applicant: Foremount Ent. Co., Ltd.. Device class: 2.

Clearance details

Applicant: Foremount Ent. Co., Ltd.
Product code: Code CBP
Device class: Class 2
Regulation: 21 CFR 868.5870
Advisory panel: Anesthesiology
Date received: 2004-10-01
Decision date: 2005-03-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Ta Ya Hsiang, Taichung, TW

Download summary PDF View on FDA.gov ↗

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