510(k) K892057
- Device
- OHMEDA TEC 5 CONTINUOUS FLOW VAPORIZER
- Applicant
- OHMEDA MEDICAL
- 510(k) number
- K892057
- Product code
- CAD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1989-04-26
- Date received
- 1989-03-29
- Regulation
- 868.5880
- Classification name
- Vaporizer, Anesthesia, Non-heated
- Medical specialty
- Anesthesiology
- Review panel
- Anesthesiology
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- No
Applicant Contact#
- Contact
- TIMOTHY M DAVIS
- Address
- Ohmeda Dr. P.O. Box 7550 Madison WI US 53707 53707
FDA Registration Numbers#
- 9610531
- 3007603826
- 9611500
- 8022032
- 2022648
- 9611295
- 3009116370
- 2221819
- 1320909
- 3009156722
- 2112667
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code CAD #
| 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 |
Legacy Summary#
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FDA Review#
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