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510(k) K923397

SINGLE DOSE GAS INJECTOR by Escalon Medical Trek — Product Code BXX

K923397 is an FDA 510(k) premarket notification submitted by Escalon Medical Trek for the device "SINGLE DOSE GAS INJECTOR". The FDA issued a decision of Substantially Equivalent on September 14, 1992. The device falls under product code BXX (Calibrator, Pressure, Gas), a Class I device regulated under 21 CFR 868.2620.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 14, 1992
Date Received
July 10, 1992
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 for product code BXX

  • K875075 — RT-200 COMPUTER INTERFACE (April 21, 1988)
  • K850029 — UTAH PRESSURE TRANSDUCER CALIBRATOR TRU-CAL (April 29, 1985)
  • 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