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FDA 510(k), K131045, ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE
FDA 510(k), K131045, ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE
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510(K) Number: K131045
Device Name: ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE
Manufacturer: RAYMOND J KELLY, IV
Device Classification Name: Computer, Diagnostic, Programmable
Regulation Number: DQK
Classification Product Code: KXA
Date Received: 04/15/2013
Decision Date: 05/29/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
Device Name: ENTERPRISE ECG ANALYSIS / INTERPRETATION SOFTWARE
Manufacturer: RAYMOND J KELLY, IV
Device Classification Name: Computer, Diagnostic, Programmable
Regulation Number: DQK
Classification Product Code: KXA
Date Received: 04/15/2013
Decision Date: 05/29/2013
Decision: Substantially Equivalent (SESE)
Regulation Medical Specialty: Cardiovascular
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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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