The following data is part of a premarket notification filed by Dre Medical, Inc. with the FDA for Dre Ventura.
| Device ID | K132903 |
| 510k Number | K132903 |
| Device Name: | DRE VENTURA |
| Classification | Gas-machine, Anesthesia |
| Applicant | DRE MEDICAL, INC. 1800 WILLIAMSON CT. Louisville, KY 40026 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden DRE MEDICAL, INC. 1800 WILLIAMSON CT. Louisville, KY 40026 |
| Product Code | BSZ |
| CFR Regulation Number | 868.5160 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-16 |
| Decision Date | 2014-07-01 |
| Summary: | summary |