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510(k) K884800

ACTA GENOS ELECTROCARDIOGRAPH by Parexel Intl. Corp. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1989
Date Received
November 16, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type

Other clearances by Parexel Intl. Corp.

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  • K904901 — L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC (March 26, 1991)
  • 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)
  • K851322 — PERSONAL C3 3-CHANNEL ELECTROCARDIOGRAPH (May 16, 1985)

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