FDA 510(k), K150137, SpiroThor
FDA 510(k), K150137, SpiroThor
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510(K) Number: K150137
Device Name: SpiroThor
Manufacturer: Cohero Health LLC
Device Classification Name: spirometer, diagnostic
Regulation Number: 868.1840
Classification Product Code: BZG
Date Received: 01/22/2015
Decision Date: 05/27/2015
Regulation Medical Specialty: Anesthesiology
Device Name: SpiroThor
Manufacturer: Cohero Health LLC
Device Classification Name: spirometer, diagnostic
Regulation Number: 868.1840
Classification Product Code: BZG
Date Received: 01/22/2015
Decision Date: 05/27/2015
Regulation Medical Specialty: Anesthesiology
- 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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