Home / 510(k) Clearances / K002878

510(k) K002878

DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER by Datex-Ohmeda, Inc. — Product Code CAD

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 21, 2000
Date Received
September 15, 2000
Clearance Type
Special
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 Datex-Ohmeda, Inc.

  • K251663 — Giraffe OmniBed Carestation (CS1); Giraffe Incubator Carestation (CS1) (October 22, 2025)
  • K213867 — Carestation 750/750c (March 28, 2023)
  • K210384 — CARESCAPE R860 (November 4, 2021)
  • K172702 — Tec 820, Tec 850 (January 4, 2018)
  • K172045 — Aestiva 7900, Aestiva MRI, Aestiva 7100, Aestiva 7100 Compact, Aespire 100, Aesp (November 3, 2017)
  • K170872 — Aisys CS2 (August 15, 2017)
  • K151570 — Carestation 620/650/650C (January 21, 2016)
  • K142679 — CARESCAPE R860 (June 12, 2015)
  • K143530 — Aespire View (April 24, 2015)
  • K140575 — ENGSTROM CARESTATION, ENGSTROM PRO (February 3, 2015)

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)