The following data is part of a premarket notification filed by Penlon Limited with the FDA for Sigma Alpha Vaporizer.
| Device ID | K060331 |
| 510k Number | K060331 |
| Device Name: | SIGMA ALPHA VAPORIZER |
| Classification | Vaporizer, Anesthesia, Non-heated |
| Applicant | PENLON LIMITED 25 BARKER CLOSE FISHBOURNE, CHICHESTER West Sussex, GB Po18 8bj |
| Contact | Barry Pearce |
| Correspondent | Barry Pearce PENLON LIMITED 25 BARKER CLOSE FISHBOURNE, CHICHESTER West Sussex, GB Po18 8bj |
| Product Code | CAD |
| CFR Regulation Number | 868.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-02-09 |
| Decision Date | 2006-05-10 |
| Summary: | summary |