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510(k) K812766

PCS-5 ACCESSORIES by Timeter Instrument Corp. — Product Code BTI

K812766 is an FDA 510(k) premarket notification submitted by Timeter Instrument Corp. for the device "PCS-5 ACCESSORIES". The FDA issued a decision of Substantially Equivalent on December 17, 1981. The device falls under product code BTI (Compressor, Air, Portable), a Class II device regulated under 21 CFR 868.6250. Timeter Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 17, 1981
Date Received
October 5, 1981
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Compressor, Air, Portable
Device Class
Class II
Regulation Number
868.6250
Review Panel
AN
Submission Type

Other clearances by Timeter Instrument Corp.

  • K875075 — RT-200 COMPUTER INTERFACE (April 21, 1988)
  • K875074 — VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000 (February 22, 1988)
  • K871603 — CRITERION II & IIA OXYGEN CONCENTRATORS (August 13, 1987)
  • K864836 — L.A.P. SPIROMETER (March 6, 1987)
  • K834274 — CRITERION I (April 13, 1984)
  • K823775 — BORDON GAGE REGULATOR #BG (January 14, 1983)
  • K822746 — RT-200 CALIBRATION ANALYZER (October 13, 1982)
  • K813234 — OHIO AIR ADAPTOR (December 8, 1981)
  • K813235 — DISS FEMALE AIR ADAPTOR (December 8, 1981)
  • K812767 — SNIFF AIR COMPRESSOR #SF-6 (November 27, 1981)

Other clearances for product code BTI

  • K131881 — OMBRA TABLE TOP COMPRESSOR (October 24, 2013)
  • K113338 — MEDICAL AIR COMPRESSOR (August 10, 2012)
  • K091871 — DK50 DS (October 23, 2009)
  • K072634 — EMG TRITON -COMP,MODEL NCA01-XXX SERIES (November 19, 2008)
  • K060781 — MEDICAL COMPRESSOR, MODELS DK50 D AND DM (October 3, 2006)
  • K051691 — MINIMATE COMPRESSOR (December 9, 2005)
  • K041781 — VENTILAIR II MEDICAL AIR COMPRESSOR (March 14, 2005)
  • K041406 — NEWPORT C250 AIR COMPRESSOR MODEL C250 (December 15, 2004)
  • K041974 — MED2000 NEBULIZER COMPRESSOR, MODELS P3, P4, P5 WITH NEBULIZER (August 24, 2004)
  • K040220 — MEDICAL AIR COMPRESSOR (June 9, 2004)

FDA data resources