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510(k) K803052

NUFFIELD ANESTHESIA VENTILATOR SER. 400 by Penlon, Inc. — Product Code BSZ

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 7, 1981
Date Received
December 2, 1980
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Gas-Machine, Anesthesia
Device Class
Class II
Regulation Number
868.5160
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 BSZ

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  • K230931 — Atlan (July 23, 2023)
  • K213867 — Carestation 750/750c (March 28, 2023)
  • K201957 — A8, A9 Anesthesia System (March 26, 2021)
  • K191027 — Flow-i Anesthesia System, Flow-c Anesthesia System, Flow-e Anesthesia System (March 18, 2020)
  • K171292 — A7 Anesthesia System (January 12, 2018)
  • K171311 — A5 Anesthesia System (January 12, 2018)
  • K172045 — Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aesp (November 3, 2017)
  • K170872 — Aisys CS2 (August 15, 2017)
  • K160665 — FLOW-i Anesthesia System C20, FLOW-i Anesthesia System C30, FLOW-i Anesthesia Sy (March 29, 2017)