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510(k) K111180

VASOMEDICAL-BIOX 12- CHANNEL AMBULATORY ECG HOLTER RECORDER MODEL 1304, VASOMEDICAL-BIOX 3- CHANNEL MINIATURE AMBULATORY by Vasomedical, Inc. — Product Code DSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 28, 2011
Date Received
April 27, 2011
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 Vasomedical, Inc.

  • K111096 — VASOMEDICAL-BIOX COMBINED 12 CHANNEL AMBULATORY ECG AND BLOOD PRESSURE RECORDER (June 24, 2011)
  • K092785 — COMBINED VASOMEDICAL-BIOX AMBULATORY ECG & BLOOD PRESSURE RECORDER & ANALYSIS SO (April 2, 2010)
  • K083820 — VASOMEDICAL BIOX CB-1305-C, 3 CHANNEL ECG HOLTER MONITOR, MODEL CB-1305-C (April 1, 2009)
  • K033617 — EECP THERAPY SYSTEM MODEL TS4 WITH/WITHOUT PLUSE OXIMETRY (March 1, 2004)
  • K020857 — EECP THERAPY SYSTEM MODEL TS3 WITH PULSE OXIMETRY AND ENHANCED EXTERNAL COUNTERP (June 14, 2002)
  • K003469 — EECP THERAPY SYSTEM, MODEL TS3 (December 6, 2000)

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