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510(k) K926233

CARDIO2 CYCLE by Ergometrix, Inc. — Product Code KRI

K926233 is an FDA 510(k) premarket notification submitted by Ergometrix, Inc. for the device "CARDIO2 CYCLE". The FDA issued a decision of Substantially Equivalent on June 4, 1993. The device falls under product code KRI (Accessory Equipment, Cardiopulmonary Bypass), a Class I device regulated under 21 CFR 870.4200.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1993
Date Received
December 11, 1992
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Accessory Equipment, Cardiopulmonary Bypass
Device Class
Class I
Regulation Number
870.4200
Review Panel
CV
Submission Type

Other clearances for product code KRI

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  • K992635 — INTERFACE MODULE IDDD (December 20, 1999)
  • K990512 — STOCKERT POWER SUPPLY UNIT FOR S3 COMPONENTS (November 23, 1999)
  • K934782 — AMMEX TUBING ORGANIZER (November 18, 1993)
  • K922404 — TUBE GRIP (November 23, 1992)
  • K892856 — NEWMARK(TM) CORONARY ARTERY BYPASS GRAFT MARKERS (November 8, 1989)
  • K884893 — CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 (January 30, 1989)
  • K884640 — CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 (January 24, 1989)
  • K874605 — HI-LO TEMP(R) MYOCARDIAL TEMPERATURE SENSOR (February 2, 1988)
  • K874925 — CPE 2000 CARDIO PULMONARY ERGOMETER (January 19, 1988)

FDA data resources