The following data is part of a premarket notification filed by Oxavita S.r.l. with the FDA for Revitalair 430f.
| Device ID | K171899 |
| 510k Number | K171899 |
| Device Name: | Revitalair 430F |
| Classification | Chamber, Hyperbaric |
| Applicant | Oxavita S.R.L. Tamborini 5813 Buenos Aires, AR |
| Contact | Eduardo Northing |
| Correspondent | Diane Sudduth Emergo Global Consulting, LLC 2500 Bee Cave Road, Building 1, Suite 300 Austin, TX 78746 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2017-06-26 |
| Decision Date | 2019-11-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B878430F0 | K171899 | 000 |