510(k) K011565
K011565 is an FDA 510(k) premarket notification submitted by Gulf Coast Hyperbarics, Inc. for the device "INFANT OXYGEN TREATMENT HOOD". The FDA issued a decision of Substantially Equivalent on August 16, 2001. The device falls under product code CBF (Chamber, Hyperbaric), a Class II device regulated under 21 CFR 868.5470. Gulf Coast Hyperbarics, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 16, 2001
- Date Received
- May 21, 2001
- Clearance Type
- Traditional
- 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