510(k) K031649
K031649 is an FDA 510(k) premarket notification submitted by Fink Engineering Pty, Ltd. for the device "SL8/DL8/TL20 HYPERBARIC OXYGEN TREATMENT FACILITIES". The FDA issued a decision of Substantially Equivalent on December 5, 2003. The device falls under product code CBF (Chamber, Hyperbaric), a Class II device regulated under 21 CFR 868.5470. Fink Engineering Pty, Ltd. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 5, 2003
- Date Received
- May 28, 2003
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chamber, Hyperbaric
- Device Class
- Class II
- Regulation Number
- 868.5470
- Review Panel
- AN
- Submission Type