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FDA 510(k), K003927, Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02
FDA 510(k), K003927, Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02
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510(K) Number: K003927
Device Name: Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02
Manufacturer: CHEEN HOUNG ENT. CO. LTD.
Device Classification Name: ventilator, emergency, manual (resuscitator)
Regulation Number: 868.5915
Classification Product Code: BTM
Date Received: 12/20/2000
Decision Date: 06/26/2001
Regulation Medical Specialty: Anesthesiology
Device Name: Y2000 MANUAL RESUSCITATOR, MODEL RUGU01/RUG02 AND RUGH01/RUGH02
Manufacturer: CHEEN HOUNG ENT. CO. LTD.
Device Classification Name: ventilator, emergency, manual (resuscitator)
Regulation Number: 868.5915
Classification Product Code: BTM
Date Received: 12/20/2000
Decision Date: 06/26/2001
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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