510(k) K011312
K011312 is an FDA 510(k) premarket notification submitted by Khrunichev State Research & Production Space Centr for the device "BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM". The FDA issued a decision of Substantially Equivalent on July 18, 2001. The device falls under product code CBF (Chamber, Hyperbaric), a Class II device regulated under 21 CFR 868.5470. Khrunichev State Research & Production Space Centr has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 18, 2001
- Date Received
- April 30, 2001
- 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