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510(k) K961598

ELS AUTOMATIC TUBING CLAMP SYSTEM by Rocky Mountain Research, Inc. — Product Code KRL

K961598 is an FDA 510(k) premarket notification submitted by Rocky Mountain Research, Inc. for the device "ELS AUTOMATIC TUBING CLAMP SYSTEM". The FDA issued a decision of Substantially Equivalent on October 29, 1996. The device falls under product code KRL (Detector, Bubble, Cardiopulmonary Bypass), a Class II device regulated under 21 CFR 870.4205. Rocky Mountain Research, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 29, 1996
Date Received
April 9, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Detector, Bubble, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4205
Review Panel
CV
Submission Type

Other clearances by Rocky Mountain Research, Inc.

  • K992857 — LEVELSENS - FLEXIBLE, MODEL 201110, LEVELSENS - RIGID, MODEL 201070 (November 10, 1999)
  • K961364 — AUTOMATIC TUBING CLAMP SYSTEM (ATC) (October 31, 1996)
  • K921993 — ELS AUTOMATIC TUBING CLAMP SYSTEM (January 5, 1994)
  • K914459 — AUTOMATIC TUBING CLAMP (June 24, 1992)

Other clearances for product code KRL

  • K103469 — STOCKERT AIR PURGE CONTROL SYSTEM MODEL 23-45-05 (January 18, 2011)
  • K090698 — CAPIOX BUBBLE TRAP WITH X-COATING (June 8, 2009)
  • K071231 — EDAC QUANTIFIER (May 17, 2007)
  • K961364 — AUTOMATIC TUBING CLAMP SYSTEM (ATC) (October 31, 1996)
  • K940651 — SARNS ULTRASONIC AIR SENSOR (May 24, 1994)
  • K935977 — SARNS AIR DETECTION SYSTEM (February 4, 1994)
  • K925661 — STOCKERT CAPS1 CARDIOPLEGIC CONTROL MODULE (May 18, 1993)
  • K925541 — STOCKERT 1/4 BUBBLE SENSOR (February 2, 1993)
  • K911632 — CAPIOX(R) BUBBLE TRAP (July 9, 1991)
  • K864619 — CAPS LOW LEVEL DETECTOR & DETECTOR/BUBBLE MONITOR (February 3, 1987)

FDA data resources