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FDA 510(k), K092003, CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE
FDA 510(k), K092003, CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE
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510(K) Number: K092003
Device Name: CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE
Manufacturer: MyCardio, LLC
Device Classification Name: ventilatory effort recorder
Regulation Number: 868.2375
Classification Product Code: MNR
Date Received: 07/02/2009
Decision Date: 09/30/2009
Regulation Medical Specialty: Anesthesiology
Device Name: CPC SLEEP DATA RECORDER, MODEL M1, AND APPLICATION SOFTWARE
Manufacturer: MyCardio, LLC
Device Classification Name: ventilatory effort recorder
Regulation Number: 868.2375
Classification Product Code: MNR
Date Received: 07/02/2009
Decision Date: 09/30/2009
Regulation Medical Specialty: Anesthesiology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks when the FOIA office is operating at regular capacity
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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