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510(k) K875074

VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000 by Timeter Instrument Corp. — Product Code KDP

K875074 is an FDA 510(k) premarket notification submitted by Timeter Instrument Corp. for the device "VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000". The FDA issued a decision of Substantially Equivalent on February 22, 1988. The device falls under product code KDP (Regulator, Vacuum), a Class II device regulated under 21 CFR 880.6740. Timeter Instrument Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 22, 1988
Date Received
December 9, 1987
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Regulator, Vacuum
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Timeter Instrument Corp.

  • K875075 — RT-200 COMPUTER INTERFACE (April 21, 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)
  • K812766 — PCS-5 ACCESSORIES (December 17, 1981)
  • K813235 — DISS FEMALE AIR ADAPTOR (December 8, 1981)
  • K813234 — OHIO AIR ADAPTOR (December 8, 1981)
  • K812767 — SNIFF AIR COMPRESSOR #SF-6 (November 27, 1981)

Other clearances for product code KDP

  • K013976 — BOEHRINGER MRI SUCTION REGULATORY (January 8, 2002)
  • K944479 — PM3300 INTERMITTENT VACUUM (December 22, 1994)
  • K942747 — MALCOLM-LYNN(TM) EOT SUCTION REG VALVE(TM) (SRV) ) (July 21, 1994)
  • K933232 — BOEHRINGER LABORATORIES SUCTION REGULATOR, MODIFIED (March 28, 1994)
  • K926140 — VACUUM POWER BODY FLUID SUCTION APPARATUS (July 27, 1993)
  • K922817 — PM3000 & PM3100 VACUUM REGULATOR (March 4, 1993)
  • K883229 — OHMEDA CONTINUOUS SUCTION REGULATOR (October 19, 1988)
  • K853155 — BOEHRINGER LAB SUCTION INTERRUPTER (October 16, 1985)
  • K850200 — SUCTION REGULATOR 7700 SERIES (March 4, 1985)
  • K843591 — INTERCEPT (October 19, 1984)

FDA data resources