The following data is part of a premarket notification filed by Inovo, Inc. with the FDA for Chad Therapeutic Evolution Electronic Oxygen Conserver With Motion.
| Device ID | K113111 |
| 510k Number | K113111 |
| Device Name: | CHAD THERAPEUTIC EVOLUTION ELECTRONIC OXYGEN CONSERVER WITH MOTION |
| 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-10-20 |
| Decision Date | 2011-12-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00814470020105 | K113111 | 000 |
| 00822383283814 | K113111 | 000 |