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510(k) K830791

UNIVERSAL MEDDARS SYSTEM by Electronics For Medicine, Inc. — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 22, 1983
Date Received
March 14, 1983
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 Electronics For Medicine, Inc.

  • K830795 — CABINET FOR MULTIPLE FUNCTION BLOCKS (May 18, 1983)
  • K792528 — RESPIRATION/APNEA AMPLIFIER MODEL 3105 (February 21, 1980)
  • K791006 — SMART BILECTRODES (June 11, 1979)
  • K790198 — MONITOR PLUG-IN MODEL M1106 ECG (March 6, 1979)
  • K790203 — INTERVAL TIMER MODEL V4295 (March 2, 1979)
  • K790185 — MODEL V 4207 INTEGRATING PLUG-IN (February 16, 1979)
  • K780107 — ANALYZER-PLUG-IN, CO2 MODEL M 3104 (January 30, 1978)
  • K770366 — ISOLATED ELECTROCARDIOGRAPH MODEL 1207 (March 1, 1977)

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