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510(k) K792147

ARM SHIELD FOR ANESTHESIA by Medical Innovations Corp. — Product Code BTX

K792147 is an FDA 510(k) premarket notification submitted by Medical Innovations Corp. for the device "ARM SHIELD FOR ANESTHESIA". The FDA issued a decision of Substantially Equivalent on December 6, 1979. The device falls under product code BTX (Board, Arm (With Cover), Sterile), a Class I device regulated under 21 CFR 878.3910. Medical Innovations Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 6, 1979
Date Received
October 22, 1979
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Board, Arm (With Cover), Sterile
Device Class
Class I
Regulation Number
878.3910
Review Panel
SU
Submission Type

Other clearances by Medical Innovations Corp.

  • K945612 — MIC NASOGASTRIC-GASTROJEJUNAL FEEDING TUBE (April 19, 1995)
  • K940548 — MIC PERCUTANEOUS ENDOSCOPIC JEJUNAL FEEDING TUBE (February 22, 1995)
  • K943685 — MIC DISPOSABLE SNARE (November 1, 1994)
  • K926581 — MIC TRANSGASTRIC JEJUNAL TUBE (September 28, 1994)
  • K921652 — MIC TRANSGASTRIC JEJUNAL FEEDING TUBE KIT (May 2, 1994)
  • K921370 — MIC GASTRO-ENTEROSTOMY TUBE MODIFICATION (May 2, 1994)
  • K924065 — MIC PEG TUBE (February 17, 1994)
  • K922667 — MIC LOW PROFILE GASTROSTOMY TUBE (December 1, 1993)
  • K913320 — MIL CM-II COAGULATION MACHINE (June 16, 1992)
  • K903531 — ANTICARDIOLIPIN ANTIBODY TEST SYSTEM (January 25, 1991)

Other clearances for product code BTX

  • K935098 — BABY BOARD (February 15, 1994)
  • K900175 — 4/1 ARMBOARD (January 24, 1990)
  • K884838 — ALLEN PRONE ARMBOARD (December 15, 1988)
  • K882524 — UNIVERSALLY ADJUSTABLE ARMBOARD (July 8, 1988)
  • K881292 — ALLEN LATERAL ARMBOARD (April 7, 1988)
  • K864670 — BOARD, ARM (WITH COVER) (January 12, 1987)
  • K833664 — ARMBOARD AND THE BOARD (December 27, 1983)
  • K830018 — SAFE-T ARM BOARD (January 26, 1983)
  • K823412 — ARM BOARD W/I.V COVERING (December 15, 1982)
  • K811419 — SPRIO-LOOP (June 12, 1981)

FDA data resources