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510(k) K822311

DISPOSABLE COLLECTION BOTTLE W/TUBING by Ohio Medical Products — Product Code GCX

K822311 is an FDA 510(k) premarket notification submitted by Ohio Medical Products for the device "DISPOSABLE COLLECTION BOTTLE W/TUBING". The FDA issued a decision of Substantially Equivalent on August 20, 1982. The device falls under product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered), a Class II device regulated under 21 CFR 880.6740. Ohio Medical Products has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 20, 1982
Date Received
August 3, 1982
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 Ohio Medical Products

  • K841733 — OHIO WASTE GAS SCAVENGING RESERVOIR (July 11, 1984)
  • K842003 — OHIO WASTE GAS SCAVENGING INTERFACE (May 23, 1984)
  • K840356 — OHIO UNITROL II ANESTHESIA GAS MACHINE (April 20, 1984)
  • K841274 — BAG-TO-VENTILATOR SELECTOR VALVE (April 13, 1984)
  • K840857 — OHIO 3000 INFANT WARMER SYSTEM (March 23, 1984)
  • K840967 — OHIO HEAT REFLECTING PATCH (March 23, 1984)
  • K840858 — OHIO 3300 INFANT WARMER SYSTEM (March 23, 1984)
  • K840453 — MEDISHIELD PVM RESPIROMETER (March 2, 1984)
  • K840452 — PREMIUM DABM DISPOS. ANES. BREATH MASK (February 17, 1984)
  • K833335 — MODULUS II ANESTHESIA GAS MACHINE (November 14, 1983)

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