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510(k) K842123

PERSONAL CL SINGLE-CHANNEL ELECTROCAR by Parexel Intl. Corp. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 16, 1984
Date Received
May 29, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector And Alarm, Arrhythmia
Device Class
Class II
Regulation Number
870.1025
Review Panel
CV
Submission Type

Other clearances by Parexel Intl. Corp.

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  • K904902 — SMA 26 TRANSDUCER (March 26, 1991)
  • K884800 — ACTA GENOS ELECTROCARDIOGRAPH (June 22, 1989)
  • K862414 — FUJI CR IMAGING PLATE (February 26, 1987)
  • K864519 — PHILIPS COMPUTED RADIOGRAPHY SYSTEM (PCR) (February 13, 1987)
  • K862415 — TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM (July 1, 1986)
  • K862416 — FTI 100 MEDICAL THERMAL IMAGER (July 1, 1986)
  • K853295 — EMODREN EXCHANGEABLE PLASTIC BELLOWS (August 20, 1985)
  • K853296 — EMODREN GUIDE NEEDLE FOR DRAINAGE TUBE & EMODREN (August 15, 1985)

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