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510(k) K780981

PORTABLE PNEUMATIC CALIBRATOR 65-150 by Pennwalt Corp. — Product Code BXX

K780981 is an FDA 510(k) premarket notification submitted by Pennwalt Corp. for the device "PORTABLE PNEUMATIC CALIBRATOR 65-150". The FDA issued a decision of Substantially Equivalent on August 2, 1978. The device falls under product code BXX (Calibrator, Pressure, Gas), a Class I device regulated under 21 CFR 868.2620. Pennwalt Corp. has at least 5 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 2, 1978
Date Received
June 14, 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 Pennwalt Corp.

  • K833241 — INTREX (October 28, 1983)
  • K801860 — S.S. WHITE-PENNWALT RENEW CALCIUM HYDROX (October 10, 1980)
  • K801274 — S.S. WHITE-PENNWALT PRELUDE PIT SEALANT (June 9, 1980)
  • K800063 — XR-710 (March 3, 1980)
  • K800133 — PANOREX II DENTAL X-RAY UNIT (March 3, 1980)

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)
  • K780838 — PERCI (July 17, 1978)

FDA data resources