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FDA 510(k), K934631, TRANSWARMER
FDA 510(k), K934631, TRANSWARMER
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510(K) Number: K934631
Device Name: TRANSWARMER
Manufacturer: PRISM TECHNOLOGIES, INC.
Device Classification Name: pack, hot or cold, disposable
Regulation Number: 890.5710
Classification Product Code: IMD
Date Received: 09/24/1993
Decision Date: 02/03/1994
Regulation Medical Specialty: Physical Medicine
Device Name: TRANSWARMER
Manufacturer: PRISM TECHNOLOGIES, INC.
Device Classification Name: pack, hot or cold, disposable
Regulation Number: 890.5710
Classification Product Code: IMD
Date Received: 09/24/1993
Decision Date: 02/03/1994
Regulation Medical Specialty: Physical Medicine
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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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