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510(k) K932714

ELECTRONIC GLOVE INTEGRITY MONITOR (EGIM) by Surface Mount Technology, Inc. — Product Code LDQ

K932714 is an FDA 510(k) premarket notification submitted by Surface Mount Technology, Inc. for the device "ELECTRONIC GLOVE INTEGRITY MONITOR (EGIM)". The FDA issued a decision of Substantially Equivalent on December 1, 1993. Surface Mount Technology, Inc. has at least 1 other 510(k) clearance on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 1, 1993
Date Received
June 4, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Other clearances by Surface Mount Technology, Inc.

  • K962961 — SUSTAINED PHONATION (September 9, 1996)

Other clearances for product code LDQ

  • K993797 — EC-7701 FLUID WARMING CABINET (January 20, 2000)
  • K992258 — HOT SHOT FLUID WARMER IV FLUIDS (January 12, 2000)
  • K981032 — PIV SYSTEM (September 2, 1998)
  • K973747 — CONTROLLED TEMPERATURE CABINET SYSTEM (May 7, 1998)
  • K955661 — ACU-HALT (December 30, 1996)
  • K955776 — ACU-LAB (June 5, 1996)
  • K945374 — ACU-HALT (August 9, 1995)
  • K944961 — PERSONAL ALARM SYSTEM (PAS) (August 7, 1995)
  • K942810 — PALCO LABS COLD POUCH (June 28, 1995)
  • K930884 — MEDICAL PROCEDURE TRAY, MODIFICATION (March 21, 1995)

FDA data resources