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FDA 510(k), K070136, AUDICOR 200 SYSTEM, MODELS 200D AND 200S
FDA 510(k), K070136, AUDICOR 200 SYSTEM, MODELS 200D AND 200S
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510(K) Number: K070136
Device Name: AUDICOR 200 SYSTEM, MODELS 200D AND 200S
Manufacturer: INOVISE MEDICAL, INC.
Device Classification Name: electrocardiograph
Regulation Number: 870.2340
Classification Product Code: DPS
Date Received: 01/16/2007
Decision Date: 04/13/2007
Regulation Medical Specialty: Cardiovascular
Device Name: AUDICOR 200 SYSTEM, MODELS 200D AND 200S
Manufacturer: INOVISE MEDICAL, INC.
Device Classification Name: electrocardiograph
Regulation Number: 870.2340
Classification Product Code: DPS
Date Received: 01/16/2007
Decision Date: 04/13/2007
Regulation Medical Specialty: Cardiovascular
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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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