The following data is part of a premarket notification filed by Oxti Corporation with the FDA for Oxti Inflation Device.
| Device ID | K122152 |
| 510k Number | K122152 |
| Device Name: | OXTI INFLATION DEVICE |
| Classification | Syringe, Balloon Inflation |
| Applicant | OXTI CORPORATION 7128 STAFFORDSHIRE STREET Houston, TX 77030 |
| Contact | Joseph J Chang |
| Correspondent | Joseph J Chang OXTI CORPORATION 7128 STAFFORDSHIRE STREET Houston, TX 77030 |
| Product Code | MAV |
| CFR Regulation Number | 870.1650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-07-20 |
| Decision Date | 2012-12-14 |
| Summary: | summary |