Product code CAD
- Device name
- Vaporizer, Anesthesia, Non-Heated
- Medical specialty
- Anesthesiology
- Device class
- 2
- Regulation number
- 868.5880
- Review panel
- AN
- Implant
- N
- Life sustaining/supporting
- N
- GMP exempt
- N
- Third party review
- Y
- Summary malfunction reporting
- Eligible
- Source
- FDA openFDA device classification dataset
Related 510(k) Records#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K240375 | V80 Anesthetic Vaporizer (V80) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-10-31 |
| K172702 | Tec 820, Tec 850 | Datex-Ohmeda, Inc. | 2018-01-04 |
| K150167 | V60 Anesthetic Vaporizer | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-06-30 |
| K110608 | SEVOFLURANE VAPORIZER ADAPTOR | Piramal Critcal Care, Inc (Formerly Minrad, Inc) | 2011-07-20 |
| K060331 | SIGMA ALPHA VAPORIZER | Penlon Limited | 2006-05-10 |
| K053564 | KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454 | Penlon Limited | 2006-03-03 |
| K051666 | GAV - GENERAL ANAESTHETIC VAPORIZER | General Anaesthetic Services Limited | 2005-08-23 |
| K042276 | D-VAPOR | Draeger Medical, Inc. | 2004-09-23 |
| K041076 | DELTA T | Penlon , Ltd. | 2004-08-09 |
| K031027 | DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE) | Datex-Ohmeda, Inc. | 2003-06-26 |
| K012924 | DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER | Datex-Ohmeda, Inc. | 2002-01-30 |
| K002343 | SIGMA DELTA | Penlon , Ltd. | 2001-06-08 |
| K002878 | DATEX-OHMEDA D-TEC PLUS ANESTHESIA VAPORIZER | Datex-Ohmeda, Inc. | 2000-09-21 |
| K000275 | DATEX-OHMEDA TEC 6 PLUS ANESTHESIA VAPORIZER, DATEX-OHMEDA TEC 6 PLUS NAD VARIANT ANESTHESIA | Datex-Ohmeda, Inc. | 2000-04-12 |
| K990132 | DATEX-OHMEDA ANESTHESIA VAPORIZER, MODEL D-TEC | Datex-Ohmeda, Inc. | 1999-01-21 |
| K980489 | VAPAMASTA 6 | Medical Industrial Equipment | 1998-08-31 |
| K980884 | SIEMENS SEVOFLURANE VAPORIZER SV 953 | Siemens Medical Solutions USA, Inc. | 1998-08-19 |
| K981773 | DRAGER-VAPOR 19.3 | Draeger Medical, Inc. | 1998-07-06 |
| K981472 | DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS | Draeger Medical, Inc. | 1998-05-07 |
| K973051 | DRAGER-VAPOR 19.1 W/PLUG SYSTEM S PLUS | Draeger Medical, Inc. | 1997-10-30 |
| K971923 | DRAGER-VAPOR 2000 | Draeger Medical, Inc. | 1997-09-16 |
| K952083 | TEC IV AND TEC V ANESTHESIA VAPORIZERS FOR SEVOFLURANE | Clover Medical Equipment Services, Inc. | 1996-10-21 |
| K961468 | QUIK-FIL VAPORIZER KEYED FILLER | Penlon , Ltd. | 1996-07-16 |
| K960944 | PPV VAPORIZER (MODIFICATION) | Penlon , Ltd. | 1996-04-02 |
| K954801 | TECHFIL | Technimeca Medic, Inc. | 1996-01-25 |
| K953748 | TECHNOFIL | Technimeca Medic, Inc. | 1996-01-25 |
| K942799 | DATUM | Blease USA, Inc. | 1995-04-13 |
| K942091 | OHMEDA TEC 5 VAPORIZER FOR USE WITH SEVOFLURANE | Ohmeda Medical | 1995-03-30 |
| K945993 | VAPOFIL | Southmedic, Inc. | 1995-02-22 |
| K942545 | SIGMA ELITE | Penlon , Ltd. | 1995-02-03 |
Related GUDID Devices#
| Primary DI | Brand | Company | Published |
|---|---|---|---|
| 10620974002038 | Quik Fil | Southmedic Incorporated | 2018-02-23 |
| 10841522118135 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-03 |
| 10841522118173 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-03 |
| 10841522118258 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-03 |
| 10841522118265 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-03 |
| 10841522118326 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-03 |
| 10841522118357 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-03 |
| 10841522118371 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-03 |
| 10841522118401 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2017-01-03 |
| 10841522118685 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-29 |
| 10841522118494 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-29 |
| 10841522118722 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-29 |
| 10841522118753 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-29 |
| 10841522118791 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-29 |
| 10841522118814 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-29 |
| 10841522118821 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-29 |
| 10841522118869 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-29 |
| 10841522118890 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-29 |
| 10841522118951 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-29 |
| 10841522118999 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-29 |
| 10841522118616 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-29 |
| 10841522118593 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-29 |
| 10841522118579 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-29 |
| 10841522118562 | Spacelabs Healthcare | SPACELABS HEALTHCARE (WASHINGTON), INC | 2016-12-29 |
| 10620974001963 | Vapofil™ | Southmedic Incorporated | 2016-09-01 |
| 10620974002021 | Antispil | Southmedic Incorporated | 2016-09-01 |
| 10620974002014 | Antispil | Southmedic Incorporated | 2016-09-01 |
| 10620974002007 | Antispil | Southmedic Incorporated | 2016-09-01 |
| 10620974001987 | Vapofil™ | Southmedic Incorporated | 2016-09-01 |
| 10620974001970 | Vapofil™ | Southmedic Incorporated | 2016-09-01 |