The following data is part of a premarket notification filed by Khrunichev State Research & Production Space Centr with the FDA for Blks-303 Mk Monoplace Hyperbaric System.
| Device ID | K011312 |
| 510k Number | K011312 |
| Device Name: | BLKS-303 MK MONOPLACE HYPERBARIC SYSTEM |
| Classification | Chamber, Hyperbaric |
| Applicant | KHRUNICHEV STATE RESEARCH & PRODUCTION SPACE CENTR 1811 COPPER RIDGE DR. San Antonio, TX 78259 -3612 |
| Contact | W T Workman |
| Correspondent | W T Workman KHRUNICHEV STATE RESEARCH & PRODUCTION SPACE CENTR 1811 COPPER RIDGE DR. San Antonio, TX 78259 -3612 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-04-30 |
| Decision Date | 2001-07-18 |