The following data is part of a premarket notification filed by Khrunichev State Research & Production Space Centr with the FDA for Monoplace Hyperbaric Oxygen Treatment System, Model Blks-307.
| Device ID | K060739 |
| 510k Number | K060739 |
| Device Name: | MONOPLACE HYPERBARIC OXYGEN TREATMENT SYSTEM, MODEL BLKS-307 |
| Classification | Chamber, Hyperbaric |
| Applicant | KHRUNICHEV STATE RESEARCH & PRODUCTION SPACE CENTR PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Jamm |
| Correspondent | Daniel Jamm KHRUNICHEV STATE RESEARCH & PRODUCTION SPACE CENTR PO BOX 7007 Deerfield, IL 60015 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-03-20 |
| Decision Date | 2006-07-21 |
| Summary: | summary |