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FDA 510(k), K973011, BPX80 BIO-PUMP (BPX80)
FDA 510(k), K973011, BPX80 BIO-PUMP (BPX80)
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$149.00 USD
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510(K) Number: K973011
Device Name: BPX80 BIO-PUMP (BPX80)
Manufacturer: THOMAS K JOHNSEN
Device Classification Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Regulation Number: KFM
Classification Product Code: 08/13/1997
Date Received: 02/25/1998
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: BPX80 BIO-PUMP (BPX80)
Manufacturer: THOMAS K JOHNSEN
Device Classification Name: Pump, Blood, Cardiopulmonary Bypass, Non-Roller Type
Regulation Number: KFM
Classification Product Code: 08/13/1997
Date Received: 02/25/1998
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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