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510(k) K850029

UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL by Utah Medical Products, Inc. — Product Code BXX

K850029 is an FDA 510(k) premarket notification submitted by Utah Medical Products, Inc. for the device "UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL". The FDA issued a decision of Substantially Equivalent on April 29, 1985. The device falls under product code BXX (Calibrator, Pressure, Gas), a Class I device regulated under 21 CFR 868.2620. Utah Medical Products, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 29, 1985
Date Received
January 4, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Pressure, Gas
Device Class
Class I
Regulation Number
868.2620
Review Panel
AN
Submission Type

Other clearances by Utah Medical Products, Inc.

  • K143424 — UTAH CVX-RIPE (August 28, 2015)
  • K123310 — FINESSE 3RD GENERATION (MODELS FINESSE+ AND FINESSEII+) (January 23, 2013)
  • K101535 — BT-CATH (January 11, 2011)
  • K063611 — SALINE/ CONTRAST MEDIA INFUSION CATHETER (May 23, 2007)
  • K001874 — PERIPHERALLY INSERTED CENTRAL CATHETER (September 25, 2000)
  • K000974 — FOWLER ENDOCURETTE, MODEL CUR-XXX (May 23, 2000)
  • K965245 — TBD (July 3, 1997)
  • K970077 — LIBERTY PLUS SYSTEM(PFS-300)/VAGINAL PROBE, LIBERTY PLUS(PFS-044) (May 23, 1997)
  • K955663 — ABC IN-LINE BLOOD SAMPLING KIT (March 17, 1997)
  • K964526 — LIBERTY RECTAL PELVIC FLOOR EXERCISER (February 10, 1997)

Other clearances for product code BXX

  • K923397 — SINGLE DOSE GAS INJECTOR (September 14, 1992)
  • K875075 — RT-200 COMPUTER INTERFACE (April 21, 1988)
  • K822746 — RT-200 CALIBRATION ANALYZER (October 13, 1982)
  • K801258 — NEEDLE COUNTER-SURE COUNT/10 COUNT (June 4, 1980)
  • K801257 — NEEDLE COUNTER-SURE COUNT/30 CT. MAGN. (June 4, 1980)
  • K801256 — NEEDLE COUNTER-SURE COUNT-DISPOSA-TRAY (June 4, 1980)
  • K791294 — SPIROCAL (August 16, 1979)
  • K780981 — PORTABLE PNEUMATIC CALIBRATOR 65-150 (August 2, 1978)
  • K780838 — PERCI (July 17, 1978)

FDA data resources