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510(k) K900385

ACTA METRA/ACTA GNOSIS FIRMWARE PACKAGE by Parexel Intl. Corp. — Product Code DSI

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 9, 1991
Date Received
January 29, 1990
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.

  • K904902 — SMA 26 TRANSDUCER (March 26, 1991)
  • K904901 — L11, L12 LINEAR AND C11, C12 CONVEX ARRAY TRANSDUC (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)
  • K862416 — FTI 100 MEDICAL THERMAL IMAGER (July 1, 1986)
  • K862415 — TYPE 633 COMPUTED RADIOGRAPHY (CR) FILM (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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