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510(k) K790213

GENERATOR, R-WAVE by Amr Co. — Product Code IYY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 22, 1979
Date Received
January 30, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Synchronizer, Electrocardiograph, Nuclear
Device Class
Class I
Regulation Number
892.1410
Review Panel
RA
Submission Type

Other clearances for product code IYY

  • K853737 — VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM) (February 13, 1986)
  • K780510 — NUCLEAR STETHOSCOPE (April 18, 1978)