The following data is part of a premarket notification filed by Reimers Systems, Inc. with the FDA for Rsi 4200.
| Device ID | K102831 |
| 510k Number | K102831 |
| Device Name: | RSI 4200 |
| Classification | Chamber, Hyperbaric |
| Applicant | REIMERS SYSTEMS, INC. 8210-D CINDERBED RD. Lorton, VA 22079 |
| Contact | Nayil Alam |
| Correspondent | Nayil Alam REIMERS SYSTEMS, INC. 8210-D CINDERBED RD. Lorton, VA 22079 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-29 |
| Decision Date | 2011-08-19 |
| Summary: | summary |