The following data is part of a premarket notification filed by Inotec Amd Ltd. with the FDA for Natrox Topical Oxygen Delivery System With Iodp.
| Device ID | K112634 |
| 510k Number | K112634 |
| Device Name: | NATROX TOPICAL OXYGEN DELIVERY SYSTEM WITH IODP |
| Classification | Chamber, Oxygen, Topical, Extremity |
| Applicant | INOTEC AMD LTD. 2995 STEVEN MARTIN DR. Fairfax, VA 22031 |
| Contact | Diane Horwitz |
| Correspondent | Diane Horwitz INOTEC AMD LTD. 2995 STEVEN MARTIN DR. Fairfax, VA 22031 |
| Product Code | KPJ |
| CFR Regulation Number | 878.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-09 |
| Decision Date | 2012-07-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05060371000233 | K112634 | 000 |
| 05060371000202 | K112634 | 000 |
| 05060371000028 | K112634 | 000 |
| 05060371000004 | K112634 | 000 |
| 05060371000325 | K112634 | 000 |
| 05060371000363 | K112634 | 000 |
| 05060371000387 | K112634 | 000 |