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510(k) K834535

NITROUS OXIDE RECYCLER by G & L Unltd. — Product Code BSF

K834535 is an FDA 510(k) premarket notification submitted by G & L Unltd. for the device "NITROUS OXIDE RECYCLER". The FDA issued a decision of Substantially Equivalent on June 7, 1984. The device falls under product code BSF (Absorber, Carbon-Dioxide), a Class I device regulated under 21 CFR 868.5310.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 7, 1984
Date Received
December 22, 1983
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 for product code BSF

  • K951093 — KAB SYSTEM (March 24, 1995)
  • K852071 — OHMEDA GMS ABOSORBER (July 15, 1985)
  • K843422 — OHMEDA BAIN CIRCUIT ADAPTER GMS ABSOR (October 23, 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