The following data is part of a premarket notification filed by Louisville Laboratories, Inc. with the FDA for Louisville Labs Oxygen Head Tent.
| Device ID | K955535 |
| 510k Number | K955535 |
| Device Name: | LOUISVILLE LABS OXYGEN HEAD TENT |
| Classification | Chamber, Hyperbaric |
| Applicant | LOUISVILLE LABORATORIES, INC. 2400 CRITTENDEN DR. Louisville, KY 40217 -1865 |
| Contact | David Phelps |
| Correspondent | David Phelps LOUISVILLE LABORATORIES, INC. 2400 CRITTENDEN DR. Louisville, KY 40217 -1865 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-12-05 |
| Decision Date | 1996-07-01 |