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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Ventilator, Emergency, Manual (Resuscitator)
510(k) Number K002846
Device Name HEADSTAR'S MANUAL EMERGENCY RESUSCITATOR
Applicant
Headstar Medical Products Co., Ltd.
No 23, Ln. 431, Hwa Chen Rd.
Hsin-Chuang City
Taipei Hsien,  CN ROC 242
Correspondent
Headstar Medical Products Co., Ltd.
No 23, Ln. 431, Hwa Chen Rd.
Hsin-Chuang City
Taipei Hsien,  CN ROC 242
Regulation Number868.5915
Classification Product Code
BTM  
Date Received09/12/2000
Decision Date 06/06/2001
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Anesthesiology
510k Review Panel Anesthesiology
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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