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510(k) K130821

INTEL-GE CARE INNOVATIONS CONNECT RCM by Intel-Ge Care Innovations, LLC — Product Code DRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 9, 2013
Date Received
March 25, 2013
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Transmitters And Receivers, Physiological Signal, Radiofrequency
Device Class
Class II
Regulation Number
870.2910
Review Panel
CV
Submission Type

Other clearances by Intel-Ge Care Innovations, LLC

  • K131585 — INTEL-GE CARE INNOVATIONS QUIETCARE (October 8, 2013)
  • K130290 — MODIFICATION TO INTEL-GE CARE IINOVATIONS GUIDE (June 4, 2013)

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