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510(k) K780838

PERCI by Micro Tronics Corp. — Product Code BXX

K780838 is an FDA 510(k) premarket notification submitted by Micro Tronics Corp. for the device "PERCI". The FDA issued a decision of Substantially Equivalent on July 17, 1978. The device falls under product code BXX (Calibrator, Pressure, Gas), a Class I device regulated under 21 CFR 868.2620. Micro Tronics Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 17, 1978
Date Received
May 22, 1978
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 Micro Tronics Corp.

  • K901797 — THE WONDER BOX (February 7, 1991)
  • K890513 — SAC 747 AND SAC 847 (SLEEP ANALYZING COMPUTERS) (April 28, 1989)
  • K863124 — MODEL 8 EEG PREAMPLIFIER (November 18, 1986)
  • K862527 — SLEEP ANALYZING COMPUTER (October 6, 1986)
  • K772005 — MYOTONE EMG MONITOR (November 23, 1977)

Other clearances for product code BXX

  • K923397 — SINGLE DOSE GAS INJECTOR (September 14, 1992)
  • 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)
  • K801257 — NEEDLE COUNTER-SURE COUNT/30 CT. MAGN. (June 4, 1980)
  • K801258 — NEEDLE COUNTER-SURE COUNT/10 COUNT (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)

FDA data resources