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FDA 510(k), K143094, QuantaFlo
FDA 510(k), K143094, QuantaFlo
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510(K) Number: K143094
Device Name: QuantaFlo
Manufacturer: BOB MCRAE
Device Classification Name: Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Regulation Number: JOM
Classification Product Code: KXA
Date Received: 10/28/2014
Decision Date: 03/05/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: QuantaFlo
Manufacturer: BOB MCRAE
Device Classification Name: Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
Regulation Number: JOM
Classification Product Code: KXA
Date Received: 10/28/2014
Decision Date: 03/05/2015
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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