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510(k) K910462

POCKET DOP 3 by Imex Medical Systems, Inc. — Product Code HEP

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 24, 1991
Date Received
February 4, 1991
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Monitor, Blood-Flow, Ultrasonic
Device Class
Class II
Regulation Number
884.2660
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)
  • K901593 — IMEX DOP-TONE II (July 2, 1990)
  • K896613 — FLAT VASCULAR PROBE (February 16, 1990)
  • K882138 — IMEXLAB 3000 VASCULAR DIAGNOSTIC RECORDER (November 7, 1988)

Other clearances for product code HEP

  • K101960 — SONOTRAX SERIES ULTRASONIC POCKET DOPPLER (August 10, 2010)
  • K023082 — BABYCARE (March 3, 2003)
  • K920353 — ULTRACELL INSTRUMENT WIPE (September 15, 1992)