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510(k) K062007

DMS 300-7 by Diagnostic Monitoring Software — Product Code DSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2006
Date Received
July 17, 2006
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Recorder, Magnetic Tape, Medical
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

Other clearances by Diagnostic Monitoring Software

  • K133014 — DMS 300-2W HOLTER ECG RECORDER (May 19, 2014)
  • K062959 — DMS 300-2, 300-3 AND 300-4 (October 16, 2006)
  • K062088 — PREMIER 11 HOLTER (August 25, 2006)
  • K911615 — HOLTER 24-HOUR ECG SYSTEM, MODEL NUMBER: DMS 300 (January 8, 1992)

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  • K230184 — Holter ECG and ABP System (September 25, 2023)
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