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510(k) K840285

NON STRESS TEST MONITOR 507 by Imex Medical Systems, Inc. — Product Code HGH

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
May 9, 1984
Date Received
January 24, 1984
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Cannula, Suction, Uterine
Device Class
Class II
Regulation Number
884.5070
Review Panel
OB
Submission Type

Other clearances by Imex Medical Systems, Inc.

  • K973556 — IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9000 (April 24, 1998)
  • K973562 — IMEX MEDICAL SYSTEMS, INC. IMEXLAB 9100 (April 15, 1998)
  • K973336 — IMEX STETHODOP (February 5, 1998)
  • K970156 — IMEX FUTURALDOP PRO (April 4, 1997)
  • K942243 — IMEX 8000 PERSONAL CASCULAR LAB (November 3, 1995)
  • K944196 — IMWXDOP IR (May 12, 1995)
  • K942441 — IMEXDOP CT+ (August 23, 1994)
  • K910462 — POCKET DOP 3 (June 24, 1991)
  • K901593 — IMEX DOP-TONE II (July 2, 1990)
  • K896613 — FLAT VASCULAR PROBE (February 16, 1990)

Other clearances for product code HGH

  • K172151 — Hysteroscopy System (April 9, 2018)
  • K161106 — PANPAC DISPOSABLE VACUUM CURETTES (January 13, 2017)
  • K140213 — DISPOSABLE ENDOSCOPIC CANNULA (March 25, 2015)
  • K093508 — RIGID CANNULAE CURVED (RC6-RC12), RIGID CANNULAE STRAIGHT (RS6-RS12) (March 4, 2010)
  • K935820 — KOLSTER METHODS (July 19, 1994)