Home / 510(k) Clearances / K992857

510(k) K992857

LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070 by Rocky Mountain Research, Inc. — Product Code DTW

K992857 is an FDA 510(k) premarket notification submitted by Rocky Mountain Research, Inc. for the device "LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070". The FDA issued a decision of Substantially Equivalent on November 10, 1999. 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. Rocky Mountain Research, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 10, 1999
Date Received
August 25, 1999
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 Rocky Mountain Research, Inc.

  • K961364 — AUTOMATIC TUBING CLAMP SYSTEM (ATC) (October 31, 1996)
  • K961598 — ELS AUTOMATIC TUBING CLAMP SYSTEM (October 29, 1996)
  • K921993 — ELS AUTOMATIC TUBING CLAMP SYSTEM (January 5, 1994)
  • K914459 — AUTOMATIC TUBING CLAMP (June 24, 1992)

Other clearances for product code DTW

  • K150530 — Level Sensor, Level Sensor Tape (May 8, 2015)
  • K041558 — STOCKERTIR PURGE CONTROL (APC) SYSTEM (July 2, 2004)
  • 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)
  • K860076 — GAMBRO ULTRASONIC BLOOD LEVEL DETECTOR ULD 10-200 (May 30, 1986)

FDA data resources