Ohmeda Tec 6 Continuous Flow Vaporizer
FDA 510(k) K913593 · Ohmeda Medical
510(k) numberK913593
Submission
- Device name
- Ohmeda Tec 6 Continuous Flow Vaporizer
- Applicant
- Ohmeda Medical
Madison, WI, US - Received
- August 13, 1991
- Decision date
- October 6, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- CAD – Vaporizer, Anesthesia, Non-Heated
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.5880
- Specialty
- Anesthesiology
Other 510(k)s with product code CAD
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K240375 | V80 Anesthetic Vaporizer (V80)CAD · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 10/31/2024SE |
| K172702 | Tec 820, Tec 850CAD · Traditional | Datex-Ohmeda, Inc. | 01/04/2018SE |
| K150167 | V60 Anesthetic VaporizerCAD · Traditional | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 06/30/2015SE |
| K110608 | Sevoflurane Vaporizer AdaptorCAD · Traditional | Piramal Critcal Care, Inc (Formerly Minrad, Inc) | 07/20/2011SE |
| K060331 | Sigma Alpha VaporizerCAD · Traditional | Penlon Limited | 05/10/2006SE |
| K053564 | Keyed Filler Bottle Adaptor, Models 53450, 53452, 53453, 53454CAD · Traditional | Penlon Limited | 03/03/2006SE |
| K051666 | Gav - General Anaesthetic VaporizerCAD · Traditional | General Anaesthetic Services Limited | 08/23/2005SE |
| K042276 | D-VaporCAD · Traditional | Draeger Medical, Inc. | 09/23/2004SE |
| K041076 | Delta TCAD · Special | Penlon , Ltd. | 08/09/2004SE |
| K031027 | Datex-Ohmeda Tec 7 Anesthesia Vaporizer (Enflurane)CAD · Special | Datex-Ohmeda, Inc. | 06/26/2003SE |
More from Datex-Ohmeda, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K123309 | Giraffe and Panda WarmersFMT · Traditional | 02/05/2013SE |
| K101788 | Giraffe OmnibedFMZ · Special | 07/21/2010SE |
| K101778 | Giraffe IncubatorFMZ · Special | 07/21/2010SE |
| K090697 | Modification to: Giraffe and Panda WarmerFMT · Special | 04/16/2009SE |
| K072157 | Modification to Giraffe and Panda Warmers (Giraffe and Panda Uninterruptible Power Supply)FMT · Special | 08/27/2007SE |
| K070377 | Giraffe and Panda WarmerFMT · Traditional | 07/11/2007SE |
| K070247 | Giraffe and Panda Bag and Mask Resuscitation SystemBTM · Traditional | 04/20/2007SE |
| K070210 | Giraffe and Panda T- Piece Resuscitation SystemBTL · Traditional | 04/20/2007SE |
| K040068 | Biliblanket Plus High Output Phototherapy SystemFMZ · Traditional | 04/16/2004SE |
| K020547 | Ohmeda Medical Giraffe IncubatorFMZ · Traditional | 05/09/2002SE |
Questions and answers
When was Ohmeda Tec 6 Continuous Flow Vaporizer cleared by the FDA?
Ohmeda Tec 6 Continuous Flow Vaporizer (K913593) received a 510(k) decision of Substantially Equivalent on October 6, 1992, 420 days after the submission was received.
What is the product code of K913593?
The FDA product code is CAD – Vaporizer, Anesthesia, Non-Heated, a Class II (moderate risk) device regulated under 21 CFR 868.5880.