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510(k) K854359

LM2000A SURGICAL SUCTION MONITOR by Engineering, Inc. — Product Code KDQ

K854359 is an FDA 510(k) premarket notification submitted by Engineering, Inc. for the device "LM2000A SURGICAL SUCTION MONITOR". The FDA issued a decision of Substantially Equivalent on March 3, 1986. The device falls under product code KDQ (Bottle, Collection, Vacuum), a Class II device regulated under 21 CFR 880.6740. Engineering, Inc. has at least 4 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 3, 1986
Date Received
October 29, 1985
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Bottle, Collection, Vacuum
Device Class
Class II
Regulation Number
880.6740
Review Panel
HO
Submission Type

Other clearances by Engineering, Inc.

  • K881521 — MODIFIED SERVO SYRINGE (May 31, 1988)
  • K862749 — LS9000 SUCTION BIOPSY NEEDLE (September 15, 1986)
  • K862476 — LS3000 CANNULA UTERINE SUCTION (July 18, 1986)
  • K854844 — LS1000 SURGICAL ASPIRATOR II (February 12, 1986)

Other clearances for product code KDQ

  • K081718 — EXPRESS CHEST DRAIN (July 25, 2008)
  • K062302 — MILLICORE AB DIGIVENT CHEST DRAINAGE SYSTEM (October 6, 2006)
  • K043582 — OCEAN CHEST DRAIN (January 21, 2005)
  • K984496 — ATRIUM MEDICAL CORPORATION EXPRESS CHEST DRAIN (May 5, 1999)
  • K962856 — PLEUR-EVAC SAHARA ADULT/PEDIATRIC CHEST DRAINAGE SYSTEM MODEL S-1100, S-1200, 2- (August 28, 1996)
  • K961287 — ROCKET PLEURASEAL II CHEST DRAINAGE SYSTEM (July 26, 1996)
  • K962168 — MUCUS SPECIMEN TRAP (July 22, 1996)
  • K950677 — ATRIUM DRY SUCTION CONTROL WATER SEAL CHEST DRAIN (April 13, 1995)
  • K941818 — PM9000 VAC TRAP (December 12, 1994)
  • K932327 — THORA-KLEX 350 ML PEDIATRIC CHEST DRAINAGE SYSTEM (July 13, 1993)

FDA data resources