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510(k) K833673

ACCURATE MEASUREMENT DEVICE EZ-AMD by Sorensen Research — Product Code GCX

K833673 is an FDA 510(k) premarket notification submitted by Sorensen Research for the device "ACCURATE MEASUREMENT DEVICE EZ-AMD". The FDA issued a decision of Substantially Equivalent on December 29, 1983. The device falls under product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered), 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
December 29, 1983
Date Received
October 18, 1983
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Apparatus, Suction, Operating-Room, Wall Vacuum Powered
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)
  • K833094 — TRANSDUCER DOME SD104 (November 3, 1983)
  • K833096 — TRANSDUCER DOME DS106 (November 3, 1983)
  • K833095 — TRANSDUCER DOME SD105 (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)
  • K831505 — THORACIC GAUGE #TG-60 -VACUUM REGULATOR (July 12, 1983)
  • K820706 — WATERLESS SEAL & VACUUM REGULATOR (April 9, 1982)
  • K813464 — DISPOSABLE TRANSDUCER (January 7, 1982)

Other clearances for product code GCX

  • K042454 — STRYKER CASSETTE PUMP (December 9, 2004)
  • K992126 — CIRCON SURGIFLEX WAVE TSUNAMI SUCTION-IRRIGATION SYSTEM (August 3, 1999)
  • K972074 — SUCTION INSTRUMENTATION (July 25, 1997)
  • K971022 — CHASE SUCKER (April 17, 1997)
  • K964127 — MEDI-VAC FLEXI-CLEAR SUCTION HANDLE (December 31, 1996)
  • K964519 — CURITY THORACENTESIS TRAY (December 20, 1996)
  • K963648 — STRYKER SUCTION REGULATOR (November 26, 1996)
  • K962920 — RENTON SUCTION DEVICE U.S. PATENT*4,767,404 (October 21, 1996)
  • K961880 — MEDCARE SUCTION CONNECTING TUBING (July 19, 1996)
  • K960223 — CPR YANKAUER (March 28, 1996)

FDA data resources