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510(k) K885085

ERGOMED 840/ERGOMED 840L by Burdick Corp. — Product Code DRT

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 3, 1989
Date Received
December 9, 1988
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)
Device Class
Class II
Regulation Number
870.2300
Review Panel
CV
Submission Type

Other clearances by Burdick Corp.

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  • K945985 — PC HOLTER SCANNING SYSTEM SIMPLICITY, ALTAIR 8200, 8300, 8400 (July 3, 1995)
  • K943959 — ECLIPSE 4 ELECTROCARDIOGRAPH (May 17, 1995)
  • K942565 — ALTAIR-DISC RECORDER (December 5, 1994)
  • K941351 — BURDICK PRO2 OXIMETER (October 13, 1994)
  • K942438 — ALTAIR 6100 CASSETTE RECORDER (August 5, 1994)
  • K903565 — E560 ELECTROCARDIOGRAPH (July 24, 1991)
  • K904032 — ELITE II ELECTROCARDIOGRAPH (July 24, 1991)

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