The following data is part of a premarket notification filed by Piramal Critcal Care, Inc (formerly Minrad, Inc) with the FDA for Sevoflurane Vaporizer Adaptor.
| Device ID | K110608 |
| 510k Number | K110608 |
| Device Name: | SEVOFLURANE VAPORIZER ADAPTOR |
| Classification | Vaporizer, Anesthesia, Non-heated |
| Applicant | PIRAMAL CRITCAL CARE, INC (FORMERLY MINRAD, INC) 50 COBHAM DRIVE Orchard Park, NY 14127 |
| Contact | Jamie Keller |
| Correspondent | Jamie Keller PIRAMAL CRITCAL CARE, INC (FORMERLY MINRAD, INC) 50 COBHAM DRIVE Orchard Park, NY 14127 |
| Product Code | CAD |
| CFR Regulation Number | 868.5880 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-03-03 |
| Decision Date | 2011-07-20 |
| Summary: | summary |