Home / 510(k) Clearances / K853737

510(k) K853737

VEST(AMBULATORY VENTRICULAR EVALUATING SYSTEM) by Capintec, Inc. — Product Code IYY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 13, 1986
Date Received
September 6, 1985
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 by Capintec, Inc.

  • K192199 — CRC PC Smart Chamber K1 (September 12, 2019)
  • K162394 — CRC-77tHR (March 8, 2017)
  • K141413 — CRC PC WITH SMART CHAMBER (June 27, 2014)
  • K101452 — CAPINTEC CRC 55T SERIES DOSE CALIBRATORS, MODELS CRC 55TR, CRC 55TPET AND CRC 55 (August 9, 2010)
  • K071396 — CRC 25 SERIES (CRC 25R, CRC 25PET, CRC 25W) DOSE CALIBRATORS (June 28, 2007)
  • K052595 — CRC 15ULTRA (November 8, 2005)
  • K030175 — 2 BASIC (April 17, 2003)
  • K020150 — CRC-15BT (August 2, 2002)
  • K982448 — CARDIOLIGHT (June 11, 1999)
  • K980402 — CAPINTEC MODEL 292 ELECTROMETER (April 24, 1998)

Other clearances for product code IYY

  • K790213 — GENERATOR, R-WAVE (March 22, 1979)
  • K780510 — NUCLEAR STETHOSCOPE (April 18, 1978)