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 |