The following data is part of a premarket notification filed by Reimers Systems, Inc. with the FDA for Ods1 - Hood Driver.
| Device ID | K962871 |
| 510k Number | K962871 |
| Device Name: | ODS1 - HOOD DRIVER |
| Classification | Chamber, Hyperbaric |
| Applicant | REIMERS SYSTEMS, INC. 7668 FULLERTON RD., SUITE I-4 Springfield, VA 22153 |
| Contact | Stephen D Reimers |
| Correspondent | Stephen D Reimers REIMERS SYSTEMS, INC. 7668 FULLERTON RD., SUITE I-4 Springfield, VA 22153 |
| Product Code | CBF |
| CFR Regulation Number | 868.5470 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-07-23 |
| Decision Date | 1996-10-23 |
| Summary: | summary |