Home / 510(k) Clearances / K852407

510(k) K852407

SENSOR TAPE CAT. NO. ST-45 by American Omni Medical, Inc. — Product Code DTW

K852407 is an FDA 510(k) premarket notification submitted by American Omni Medical, Inc. for the device "SENSOR TAPE CAT. NO. ST-45". The FDA issued a decision of Substantially Equivalent on October 21, 1985. The device falls under product code DTW (Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4340. American Omni Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 21, 1985
Date Received
June 6, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor And/Or Control, Level Sensing, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4340
Review Panel
CV
Submission Type

Other clearances by American Omni Medical, Inc.

  • K922781 — FLOW CONROL VALVE (March 8, 1993)
  • K922356 — FLOW CONTROL VALVE, CAT. NO. ACV-38 (February 12, 1993)
  • K900672 — PREBYPASS FILTER, CAT. NO. FPB-5 (April 3, 1990)
  • K884893 — CARDIOTOMY RESERVOIR VALVE NO. CRV-30 OR PCRV-25 (January 30, 1989)
  • K884640 — CARDIOPLEGIA OVERPRESSURE VALVE CPOP-350 & 700 (January 24, 1989)
  • K873316 — BUBBLE TRAP-FILTER CAT. NO B180F37 (July 14, 1988)
  • K875080 — AIR VENT LINE CAT. NO. AVL-36 (February 29, 1988)
  • K873802 — PRESSURE BARRIER KIT CAT. NO. PBK-3 (November 6, 1987)
  • K873610 — PEDIATRIC BUBBLE TRAP CAT. NO. B-100 (November 5, 1987)
  • K873488 — SILENT GUARD CAT. NO. SG-10 (October 7, 1987)

Other clearances for product code DTW

  • K150530 — Level Sensor, Level Sensor Tape (May 8, 2015)
  • K041558 — STOCKERTIR PURGE CONTROL (APC) SYSTEM (July 2, 2004)
  • K992857 — LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070 (November 10, 1999)
  • K955152 — STOCKERT S3 UPS, LVL CTRL BUBB. DET., DUAL PRESS. CTRL., TEMP MONT., TIMER (February 22, 1996)
  • K910599 — CARDIOPULMONARY BYPASS LEVEL SENSING MONITOR (May 20, 1993)
  • K924354 — STOCKERT CAPS LOW LEVEL DETECT II/BUBBLE MONITOR (February 18, 1993)
  • K915337 — CAPIOX LEVEL ALARM (February 21, 1992)
  • K900910 — COBE AIR EMBOLI PROTECTION SYSTEM (AEPS) (May 22, 1990)
  • K900815 — SARNS 9000 PERFUSION SYSTEM W/ALERT ONLY LEVEL (May 9, 1990)
  • K873206 — MYOCARDIAL TEMP. SENSOR W/TYPE T THERMOCOUPLE (September 30, 1987)

FDA data resources