SIGMA ELITE
FDA 510(k) clearance K936046 · decided 1994-11-04
Clearance details
- K-number
- K936046
- Device name
- SIGMA ELITE
- Applicant
- Penlon, Inc.
- Decision
- Substantially Equivalent
- Date received
- 1993-12-20
- Decision date
- 1994-11-04
- Days to decision
- 319 days
- Clearance type
- Traditional
- Product code
- CAD
- Device class
- 2
- Regulation number
- 868.5880
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- Abingdon Ox, GB
- Third-party review
- No
- Expedited review
- No
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Similar devices under this product code
Devices cleared under the same product code - the starting set for predicate research.
| Record | Firm | Date |
|---|---|---|
| V80 Anesthetic Vaporizer (V80) (K240375) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2024-10-31 |
| Tec 820, Tec 850 (K172702) | Datex-Ohmeda, Inc. | 2018-01-04 |
| V60 Anesthetic Vaporizer (K150167) | Shenzhen Mindray Bio-Medical Electronics Co., Ltd. | 2015-06-30 |
| SEVOFLURANE VAPORIZER ADAPTOR (K110608) | Piramal Critcal Care, Inc (Formerly Minrad, Inc) | 2011-07-20 |
| SIGMA ALPHA VAPORIZER (K060331) | Penlon Limited | 2006-05-10 |
| KEYED FILLER BOTTLE ADAPTOR, MODELS 53450, 53452, 53453, 53454 (K053564) | Penlon Limited | 2006-03-03 |
| GAV - GENERAL ANAESTHETIC VAPORIZER (K051666) | General Anaesthetic Services Limited | 2005-08-23 |
| D-VAPOR (K042276) | Draeger Medical, Inc. | 2004-09-23 |
| DELTA T (K041076) | Penlon , Ltd. | 2004-08-09 |
| DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (ENFLURANE) (K031027) | Datex-Ohmeda, Inc. | 2003-06-26 |
| DATEX-OHMEDA TEC 7 ANESTHESIA VAPORIZER (K012924) | Datex-Ohmeda, Inc. | 2002-01-30 |
| SIGMA DELTA (K002343) | Penlon , Ltd. | 2001-06-08 |
Recalls involving this device
No recalls on record reference this clearance.