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510(k) K873489

EMERSON DISPOS THORACIC DRAINAGE SET - 551-8000 by J. H. Emerson Co. — Product Code GCX

K873489 is an FDA 510(k) premarket notification submitted by J. H. Emerson Co. for the device "EMERSON DISPOS THORACIC DRAINAGE SET - 551-8000". The FDA issued a decision of Substantially Equivalent on December 29, 1987. The device falls under product code GCX (Apparatus, Suction, Operating-Room, Wall Vacuum Powered), a Class II device regulated under 21 CFR 880.6740. J. H. Emerson Co. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 29, 1987
Date Received
August 31, 1987
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 J. H. Emerson Co.

  • K002598 — EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL (November 22, 2000)
  • K920910 — OXYGEN POWERED RESUSCITATOR FOR CPR (January 12, 1993)
  • K924174 — EMERSON IN-EXSUFFLATOR, MODELS 2-CM & 2-CA (November 17, 1992)
  • K902764 — EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM (November 19, 1990)
  • K896721 — MODEL 7-AT TREATMENT CHAMBER (January 22, 1990)
  • K881808 — EMERSON CHEST RESPIRATOR, MODEL 33-CRE (August 4, 1988)
  • K872936 — 97-D EMERSON DIMMER CONTROL (September 24, 1987)
  • K872937 — 97-TD EMERSON TIMER/DIMMER CONTROL (September 24, 1987)
  • K864379 — EMERSON 3MV VOLUME VENTILATOR (December 15, 1986)
  • K864394 — EMERSON 3MV VOLUME VENTILATOR (December 5, 1986)

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