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510(k) K834224

VACUUM REGULATOR 0-2000 MMHG VR-1000 by Trimeter Instrument Corp. — Product Code KDP

K834224 is an FDA 510(k) premarket notification submitted by Trimeter Instrument Corp. for the device "VACUUM REGULATOR 0-2000 MMHG VR-1000". The FDA issued a decision of Substantially Equivalent on February 27, 1984. The device falls under product code KDP (Regulator, Vacuum), a Class II device regulated under 21 CFR 880.6740.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 27, 1984
Date Received
December 6, 1983
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 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)
  • K875074 — VACUMATE INTERMITTENT/CONTINUOUS CONTROLLER,VM2000 (February 22, 1988)
  • K853155 — BOEHRINGER LAB SUCTION INTERRUPTER (October 16, 1985)
  • K850200 — SUCTION REGULATOR 7700 SERIES (March 4, 1985)

FDA data resources