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FDA 510(k), K971198, BABYTHERM 8004 BABYTHERM 8010
FDA 510(k), K971198, BABYTHERM 8004 BABYTHERM 8010
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510(K) Number: K971198
Device Name: BABYTHERM 8004 BABYTHERM 8010
Manufacturer: DRAGER, INC.
Device Classification Name: warmer, infant radiant
Regulation Number: 880.5130
Classification Product Code: FMT
Date Received: 03/31/1997
Decision Date: 10/03/1997
Regulation Medical Specialty: General Hospital
Device Name: BABYTHERM 8004 BABYTHERM 8010
Manufacturer: DRAGER, INC.
Device Classification Name: warmer, infant radiant
Regulation Number: 880.5130
Classification Product Code: FMT
Date Received: 03/31/1997
Decision Date: 10/03/1997
Regulation Medical Specialty: General Hospital
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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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