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FDA 510(k), K992703, CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800
FDA 510(k), K992703, CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800
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510(K) Number: K992703
Device Name: CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800
Manufacturer: PREMIER HEART, LLC.
Device Classification Name: computer, diagnostic, programmable
Regulation Number: 870.1425
Classification Product Code: DQK
Date Received: 08/12/1999
Decision Date: 03/21/2000
Regulation Medical Specialty: Cardiovascular
Device Name: CARDIOTRON EKG MULTI-PHASE INFORMATION ANALYSIS SYSTEM, MODELS 3800, 6800, 8800
Manufacturer: PREMIER HEART, LLC.
Device Classification Name: computer, diagnostic, programmable
Regulation Number: 870.1425
Classification Product Code: DQK
Date Received: 08/12/1999
Decision Date: 03/21/2000
Regulation Medical Specialty: Cardiovascular
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
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