Vapofil
FDA 510(k) K945993 · Southmedic, Inc.
510(k) numberK945993
Submission
- Device name
- Vapofil
- Applicant
- Southmedic, Inc.
Barrie, Ontario Canada, CA - Received
- November 18, 1994
- Decision date
- February 22, 1995
- 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 |
|---|---|---|
| K222511 | Oxy2ProCCK · Traditional | 11/21/2023SE |
| K131410 | CO2/O2 Nasal Cannula (with 4 (10CM) O2 and CO2 Tube), CO2/O2 Nasal Cannula (with 8…CCK · Traditional | 01/13/2014SE |
| K101953 | SMDIA-1000CAF · Traditional | 01/07/2011SE |
| K014211 | Oxyarm CO2CCK · Traditional | 06/11/2002SE |
| K923265 | Funnel AdaptorCAD · Traditional | 03/18/1993SE |
| K863318 | Aerosol-TBZA · Traditional | 09/11/1986SE |
| K861839 | VapofilCAD · Traditional | 05/21/1986SE |
| K860545 | Vaporizer SpacerCAD · Traditional | 04/17/1986SE |
| K843993 | Anaeslock Three Vaporizer Interlock HVA003CAD · Traditional | 11/15/1984SE |
Questions and answers
When was Vapofil cleared by the FDA?
Vapofil (K945993) received a 510(k) decision of Substantially Equivalent on February 22, 1995, 96 days after the submission was received.
What is the product code of K945993?
The FDA product code is CAD – Vaporizer, Anesthesia, Non-Heated, a Class II (moderate risk) device regulated under 21 CFR 868.5880.