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510(k) K101022

PULMOTRACK 5050 WHOLTER, MODEL 5050 by Karmelsonix — Product Code DSH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 2010
Date Received
April 13, 2010
Clearance Type
Traditional
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 Karmelsonix

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  • K071955 — WIM-PC, MODEL 1010 (November 1, 2007)

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  • K233110 — Carnation Ambulatory Monitor (November 22, 2023)
  • K230184 — Holter ECG and ABP System (September 25, 2023)
  • K231289 — S-Patch Ex Wearable ECG Patch (August 30, 2023)