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510(k) K914459

AUTOMATIC TUBING CLAMP by Rocky Mountain Research, Inc. — Product Code FIG

K914459 is an FDA 510(k) premarket notification submitted by Rocky Mountain Research, Inc. for the device "AUTOMATIC TUBING CLAMP". The FDA issued a decision of Substantially Equivalent on June 24, 1992. The device falls under product code FIG (Clamp, Tubing, Blood, Automatic), a Class II device regulated under 21 CFR 876.5820. Rocky Mountain Research, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1992
Date Received
October 7, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Clamp, Tubing, Blood, Automatic
Device Class
Class II
Regulation Number
876.5820
Review Panel
GU
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)
  • K961598 — ELS AUTOMATIC TUBING CLAMP SYSTEM (October 29, 1996)
  • K921993 — ELS AUTOMATIC TUBING CLAMP SYSTEM (January 5, 1994)

Other clearances for product code FIG

  • K093915 — DEKA TAC DEVICE (August 23, 2011)
  • K921993 — ELS AUTOMATIC TUBING CLAMP SYSTEM (January 5, 1994)
  • K770535 — C-DAK 3500 (April 15, 1977)

FDA data resources