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510(k) K831505

THORACIC GAUGE #TG-60 -VACUUM REGULATOR by Sorensen Research — Product Code KDP

K831505 is an FDA 510(k) premarket notification submitted by Sorensen Research for the device "THORACIC GAUGE #TG-60 -VACUUM REGULATOR". The FDA issued a decision of Substantially Equivalent on July 12, 1983. The device falls under product code KDP (Regulator, Vacuum), a Class II device regulated under 21 CFR 880.6740. Sorensen Research has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 12, 1983
Date Received
May 11, 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 by Sorensen Research

  • K833674 — ACCURATE MEASUREMENT DEVICE KG-AMD (January 25, 1984)
  • K833673 — ACCURATE MEASUREMENT DEVICE EZ-AMD (December 29, 1983)
  • K833094 — TRANSDUCER DOME SD104 (November 3, 1983)
  • K833095 — TRANSDUCER DOME SD105 (November 3, 1983)
  • K833096 — TRANSDUCER DOME DS106 (November 3, 1983)
  • K832957 — FLOW-DIRECTED HEPARIN COATED THERMODIL (September 29, 1983)
  • K831506 — DISP. TRANSDUCER W/MONITORING KIT TRANS (August 12, 1983)
  • K831939 — TALL FLOOR STAND TFS-01 (July 19, 1983)
  • K820706 — WATERLESS SEAL & VACUUM REGULATOR (April 9, 1982)
  • K813464 — DISPOSABLE TRANSDUCER (January 7, 1982)

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