The following data is part of a premarket notification filed by Reimers Systems, Inc. with the FDA for T Class Hyperbaric Facilities.
Device ID | K954387 |
510k Number | K954387 |
Device Name: | T CLASS HYPERBARIC FACILITIES |
Classification | Chamber, Hyperbaric |
Applicant | REIMERS SYSTEMS, INC. 7668 FULLERTON RD. Springfield, VA 22153 -2818 |
Contact | Stephen D Reimers |
Correspondent | Stephen D Reimers REIMERS SYSTEMS, INC. 7668 FULLERTON RD. Springfield, VA 22153 -2818 |
Product Code | CBF |
CFR Regulation Number | 868.5470 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-08-19 |
Decision Date | 1995-12-15 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00850011262009 | K954387 | 000 |