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510(k) K091696

SAVI WIRELESS, MODEL PM500 by Medicomp, Inc. — Product Code DRG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 26, 2009
Date Received
June 10, 2009
Clearance Type
Special
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

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  • K883103 — EPICARDIA PC/FC (September 22, 1988)
  • K881770 — EPICARDIA LE/FD (May 31, 1988)

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