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FDA 510(k), K002768, ACAPELLA
FDA 510(k), K002768, ACAPELLA
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510(K) Number: K002768
Device Name: ACAPELLA
Manufacturer: LAWRENCE WEINSTEIN
Device Classification Name: Spirometer, Therapeutic (Incentive)
Regulation Number: BWF
Classification Product Code: 09/06/2000
Date Received: 12/05/2000
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
Device Name: ACAPELLA
Manufacturer: LAWRENCE WEINSTEIN
Device Classification Name: Spirometer, Therapeutic (Incentive)
Regulation Number: BWF
Classification Product Code: 09/06/2000
Date Received: 12/05/2000
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Anesthesiology
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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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