510(k) K990927
K990927 is an FDA 510(k) premarket notification submitted by Perry Baromedical Corp. for the device "SIGMA 3400 MONOPLACE HYPERBARIC CHAMBER". The FDA issued a decision of Substantially Equivalent on November 12, 1999. The device falls under product code CBF (Chamber, Hyperbaric), a Class II device regulated under 21 CFR 868.5470. Perry Baromedical Corp. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 1999
- Date Received
- March 19, 1999
- 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