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 |