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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Valve, Non-Rebreathing
510(k) Number K042727
Device Name POCKET SIZE RESUSCITATOR/MODEL: M16201R AND M16201A
Applicant
Foremount Ent. Co., Ltd.
9f-4, #1 Ln. 641
Shen-Lin S. Rd.
Ta Ya Hsiang, Taichung,  TW 428
Applicant Contact TYSON HSU
Correspondent
Foremount Ent. Co., Ltd.
9f-4, #1 Ln. 641
Shen-Lin S. Rd.
Ta Ya Hsiang, Taichung,  TW 428
Correspondent Contact TYSON HSU
Regulation Number868.5870
Classification Product Code
CBP  
Date Received10/01/2004
Decision Date 03/18/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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