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510(k) K021470

SEER LIGHT COMPACT DIGITAL HOLTER RECORDER by General Electric Medical Systems Information Techn — Product Code MWJ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 14, 2002
Date Received
May 8, 2002
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph, Ambulatory (Without Analysis)
Device Class
Class II
Regulation Number
870.2800
Review Panel
CV
Submission Type

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  • K020524 — PATIENTNET MONITORING SYSTEM (March 20, 2002)
  • K012467 — SOLAR 8000M SYSTEM (February 11, 2002)
  • K014108 — MAC 5000 ECG ANALYSIS SYSTEM (January 10, 2002)

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