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510(k) K801255

PENLON JUMBO CARBON DIOXIDE ABSORBER by Penlon, Inc. — Product Code BSF

K801255 is an FDA 510(k) premarket notification submitted by Penlon, Inc. for the device "PENLON JUMBO CARBON DIOXIDE ABSORBER". The FDA issued a decision of Substantially Equivalent on June 4, 1980. The device falls under product code BSF (Absorber, Carbon-Dioxide), a Class I device regulated under 21 CFR 868.5310. Penlon, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 4, 1980
Date Received
May 28, 1980
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 Penlon, Inc.

  • K061102 — PRIMA ANAESTHESIA MACHINE (July 28, 2006)
  • K041076 — DELTA T (August 9, 2004)
  • K010318 — PRIMA OXYGEN MONITOR (July 23, 2001)
  • K010317 — AV 800 VENTILATOR (July 23, 2001)
  • K002343 — SIGMA DELTA (June 8, 2001)
  • K961468 — QUIK-FIL VAPORIZER KEYED FILLER (July 16, 1996)
  • K960944 — PPV VAPORIZER (MODIFICATION) (April 2, 1996)
  • K953179 — CLM LARYNGOSCOPE (October 6, 1995)
  • K942545 — SIGMA ELITE (February 3, 1995)
  • K936046 — SIGMA ELITE (November 4, 1994)

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)
  • K834535 — NITROUS OXIDE RECYCLER (June 7, 1984)
  • K833452 — OHIO GMS ABSORBER (November 29, 1983)
  • K821144 — OHIO ABSORBER (May 28, 1982)
  • K760076 — ABSORBER, ANESTHESIA CIRCLE SYS, CO2 (July 16, 1976)

FDA data resources