The following data is part of a premarket notification filed by Diacor, Inc. with the FDA for Centralite Backpointer.
| Device ID | K954414 |
| 510k Number | K954414 |
| Device Name: | CENTRALITE BACKPOINTER |
| Classification | Monitor, Patient Position, Light-beam |
| Applicant | DIACOR, INC. 3191 SOUTH 3300 EAST, SUITE 100-A Salt Lake City, UT 84109 |
| Contact | Glenn N Waterman |
| Correspondent | Glenn N Waterman DIACOR, INC. 3191 SOUTH 3300 EAST, SUITE 100-A Salt Lake City, UT 84109 |
| Product Code | IWE |
| CFR Regulation Number | 892.5780 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-21 |
| Decision Date | 1995-10-23 |