The following data is part of a premarket notification filed by Inovo, Inc. with the FDA for Inovo, Inc. Accupulse Single Lumen Conserving Regulator.
| Device ID | K060751 |
| 510k Number | K060751 |
| Device Name: | INOVO, INC. ACCUPULSE SINGLE LUMEN CONSERVING REGULATOR |
| Classification | Conserver, Oxygen |
| Applicant | INOVO, INC. 2975 S. HORSESHOE DRIVE SUITE 600 Naples, FL 34104 |
| Contact | Michael T Dildine |
| Correspondent | Michael T Dildine INOVO, INC. 2975 S. HORSESHOE DRIVE SUITE 600 Naples, FL 34104 |
| Product Code | NFB |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-21 |
| Decision Date | 2006-07-18 |
| Summary: | summary |