The following data is part of a premarket notification filed by Fink Engineering Pty Ltd with the FDA for Sl8/dl8/tl20 Hyperbaric Oxygen Treatment Facilities.
| Device ID | K031649 |
| 510k Number | K031649 |
| Device Name: | SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES |
| Classification | Chamber, Hyperbaric |
| Applicant | FINK ENGINEERING PTY LTD 18111 COPPER RIDGE DRIVE San Antonio, TX 78259 |
| Contact | W.t. Workman |
| Correspondent | W.t. Workman FINK ENGINEERING PTY LTD 18111 COPPER RIDGE DRIVE San Antonio, TX 78259 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | Yes |
| Date Received | 2003-05-28 |
| Decision Date | 2003-12-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B718DL82130 | K031649 | 000 |
| B718DL82030 | K031649 | 000 |