The following data is part of a premarket notification filed by Vascular One, Inc. with the FDA for Vx-400 Topical Hyperbaric Oxygen Chamber.
| Device ID | K022028 |
| 510k Number | K022028 |
| Device Name: | VX-400 TOPICAL HYPERBARIC OXYGEN CHAMBER |
| Classification | Chamber, Oxygen, Topical, Extremity |
| Applicant | VASCULAR ONE, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Contact | Susan D Goldstein-falk |
| Correspondent | Susan D Goldstein-falk VASCULAR ONE, INC. 55 Northern Blvd. Suite 200 Great Neck, NY 11021 |
| Product Code | KPJ |
| CFR Regulation Number | 878.5650 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-06-21 |
| Decision Date | 2002-12-17 |
| Summary: | summary |