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FDA 510(k), K981415, 0-20 CM H20 PEEP VALVE
FDA 510(k), K981415, 0-20 CM H20 PEEP VALVE
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510(K) Number: K981415
Device Name: 0-20 CM H20 PEEP VALVE
Manufacturer: CHEEN HOUNG ENT. CO. LTD.
Device Classification Name: attachment, breathing, positive end expiratory pressure
Regulation Number: 868.5965
Classification Product Code: BYE
Date Received: 04/20/1998
Decision Date: 07/14/1998
Regulation Medical Specialty: Anesthesiology
Device Name: 0-20 CM H20 PEEP VALVE
Manufacturer: CHEEN HOUNG ENT. CO. LTD.
Device Classification Name: attachment, breathing, positive end expiratory pressure
Regulation Number: 868.5965
Classification Product Code: BYE
Date Received: 04/20/1998
Decision Date: 07/14/1998
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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