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510(k) K951093

KAB SYSTEM by King Systems Corp. — Product Code BSF

K951093 is an FDA 510(k) premarket notification submitted by King Systems Corp. for the device "KAB SYSTEM". The FDA issued a decision of Substantially Equivalent on March 24, 1995. The device falls under product code BSF (Absorber, Carbon-Dioxide), a Class I device regulated under 21 CFR 868.5310. King Systems Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 24, 1995
Date Received
March 9, 1995
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Absorber, Carbon-Dioxide
Device Class
Class I
Regulation Number
868.5310
Review Panel
AN
Submission Type

Other clearances by King Systems Corp.

  • K033189 — KING LTS REUSABLE OROPHARYNGEAL AIRWAY WITH DRAIN/SUCTION CHANNEL, MODELS KLT 30 (May 4, 2004)
  • K033186 — KING LT-D DISPOSABLE OROPHARYNGEAL AIRWAY, MODELS KLT 203, KLT 204 AND KLT 205 (April 14, 2004)
  • K021634 — KING LT, MODELS # KLT 100, KLT 101, KLT 102, KLT 103, KLT 104, KLT 105 (January 9, 2003)
  • K012485 — MS-140 ALL-ROUND ENHANCED PERFORMANCE FILTER; MS-141 ALL-ROUND ENHANCED PERFORMA (October 9, 2001)
  • K010040 — SLEEVED FILTER (March 9, 2001)
  • K990614 — HME-BOOSTER (May 23, 2000)
  • K983817 — BREATHING CIRCUIT BACTERIAL FILTER/HEAT AND MOISTURE EXCHANGER (HME/F) (March 1, 1999)
  • K973797 — BREATHING CIRCUIT BACTERIAL FILTER (March 12, 1998)
  • K953513 — XENON CIRCUIT (November 3, 1995)
  • K950318 — FLEX BLUE (February 13, 1995)

Other clearances for product code BSF

  • K852071 — OHMEDA GMS ABOSORBER (July 15, 1985)
  • K843422 — OHMEDA BAIN CIRCUIT ADAPTER GMS ABSOR (October 23, 1984)
  • K834535 — NITROUS OXIDE RECYCLER (June 7, 1984)
  • K833452 — OHIO GMS ABSORBER (November 29, 1983)
  • K821144 — OHIO ABSORBER (May 28, 1982)
  • K801255 — PENLON JUMBO CARBON DIOXIDE ABSORBER (June 4, 1980)
  • K760076 — ABSORBER, ANESTHESIA CIRCLE SYS, CO2 (July 16, 1976)

FDA data resources