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510(k) K936046

SIGMA ELITE by Penlon, Inc. — Product Code CAD

K936046 is an FDA 510(k) premarket notification submitted by Penlon, Inc. for the device "SIGMA ELITE". The FDA issued a decision of Substantially Equivalent on November 4, 1994. The device falls under product code CAD (Vaporizer, Anesthesia, Non-Heated), a Class II device regulated under 21 CFR 868.5880. Penlon, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
November 4, 1994
Date Received
December 20, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Vaporizer, Anesthesia, Non-Heated
Device Class
Class II
Regulation Number
868.5880
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)
  • K902381 — PENLON BREATHING SYSTEM PRESSURE MONITOR (August 17, 1990)

Other clearances for product code CAD

  • K240375 — V80 Anesthetic Vaporizer (V80) (October 31, 2024)
  • K172702 — Tec 820, Tec 850 (January 4, 2018)
  • K150167 — V60 Anesthetic Vaporizer (June 30, 2015)
  • K110608 — SEVOFLURANE VAPORIZER ADAPTOR (July 20, 2011)
  • K060331 — SIGMA ALPHA VAPORIZER (May 10, 2006)
  • K053564 — KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454 (March 3, 2006)
  • K051666 — GAV - GENERAL ANAESTHETIC VAPORIZER (August 23, 2005)
  • K042276 — D-VAPOR (September 23, 2004)
  • K041076 — DELTA T (August 9, 2004)
  • K031027 — DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE) (June 26, 2003)

FDA data resources