The following data is part of a premarket notification filed by Electrochemical Oxygen Concepts, Inc. with the FDA for Tanscu O2.
| Device ID | K090681 |
| 510k Number | K090681 |
| Device Name: | TANSCU O2 |
| Classification | Chamber, Oxygen, Topical, Extremity |
| Applicant | ELECTROCHEMICAL OXYGEN CONCEPTS, INC. 10 E SCRANTON AVE SUITE 201 Lake Bluff, IL 60044 |
| Contact | Carl Jenkins |
| Correspondent | Carl Jenkins ELECTROCHEMICAL OXYGEN CONCEPTS, INC. 10 E SCRANTON AVE SUITE 201 Lake Bluff, IL 60044 |
| Product Code | KPJ |
| CFR Regulation Number | 878.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-03-16 |
| Decision Date | 2009-08-12 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00851404004121 | K090681 | 000 |
| 00851404004022 | K090681 | 000 |
| 00851404004039 | K090681 | 000 |
| 00851404004046 | K090681 | 000 |
| 00851404004060 | K090681 | 000 |
| 00851404004077 | K090681 | 000 |
| 00851404004084 | K090681 | 000 |
| 00851404004091 | K090681 | 000 |
| 00851404004107 | K090681 | 000 |
| 00851404004114 | K090681 | 000 |
| 00851404004015 | K090681 | 000 |