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510(k) K780107

ANALYZER-PLUG-IN, CO2 MODEL M 3104 by Electronics For Medicine, Inc. — Product Code CCK

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 30, 1978
Date Received
January 19, 1978
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase
Device Class
Class II
Regulation Number
868.1400
Review Panel
AN
Submission Type

Other clearances by Electronics For Medicine, Inc.

  • K830791 — UNIVERSAL MEDDARS SYSTEM (June 22, 1983)
  • 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)
  • K770366 — ISOLATED ELECTROCARDIOGRAPH MODEL 1207 (March 1, 1977)

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