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510(k) K921993

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

K921993 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 January 5, 1994. 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
January 5, 1994
Date Received
April 28, 1992
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)
  • K914459 — AUTOMATIC TUBING CLAMP (June 24, 1992)

Other clearances for product code FIG

  • K093915 — DEKA TAC DEVICE (August 23, 2011)
  • K914459 — AUTOMATIC TUBING CLAMP (June 24, 1992)
  • K770535 — C-DAK 3500 (April 15, 1977)

FDA data resources