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510(k) K780510

NUCLEAR STETHOSCOPE by Bios, Inc. — Product Code IYY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 18, 1978
Date Received
March 30, 1978
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

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  • K230755 — NuEra Tight RF Model OptiStream (October 30, 2023)
  • K223856 — NuEra Tight RF Family (August 11, 2023)
  • K223907 — NuEra Tight RF Model APMD145.M70-US (May 2, 2023)
  • K210867 — NuEra Tight RF, NuEra Tight RF Plus (April 21, 2021)
  • K201239 — NuEra Tight Family, EMS Model (December 31, 2020)
  • K200359 — NuEra Tight, NuEra Tight EMS (August 11, 2020)
  • K161632 — FAMILY OF SQUARE EPIL (Alex, Alex2, Nd:Yag, Alex+Nd:Yag) (December 8, 2016)
  • K153229 — Superbium (April 12, 2016)

Other clearances for product code IYY

  • K853737 — VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM) (February 13, 1986)
  • K790213 — GENERATOR, R-WAVE (March 22, 1979)