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510(k) K172702

Tec 820, Tec 850 by Datex-Ohmeda, Inc. — Product Code CAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 4, 2018
Date Received
September 7, 2017
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

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Other clearances for product code CAD

  • K240375 — V80 Anesthetic Vaporizer (V80) (October 31, 2024)
  • 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)
  • K012924 — DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (January 30, 2002)