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510(k) K092809

HRV ACQUIRE by Wr Medical Electronics Co. — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 19, 2010
Date Received
September 11, 2009
Clearance Type
Abbreviated
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Wr Medical Electronics Co.

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  • K992874 — Q-SWEAT QUANTITATIVE SWEAT MEASUREMENT SYSTEM (November 18, 1999)
  • K910624 — CASE IV COMPUTER AIDED SENSORY EVALUATOR VERSION 4 (January 17, 1992)
  • K895838 — BRACKMANN EMG MONITORING SYSTEM (March 27, 1990)

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