The following data is part of a premarket notification filed by Trac Medical, Inc. with the FDA for Bedside Butler.
| Device ID | K944345 |
| 510k Number | K944345 |
| Device Name: | BEDSIDE BUTLER |
| Classification | System, Environmental Control, Powered |
| Applicant | TRAC MEDICAL, INC. 4106 WAKE FOREST RD. Raliegh, NC 27609 |
| Contact | Terry N Williams |
| Correspondent | Terry N Williams TRAC MEDICAL, INC. 4106 WAKE FOREST RD. Raliegh, NC 27609 |
| Product Code | IQA |
| CFR Regulation Number | 890.3725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-09-06 |
| Decision Date | 1994-10-17 |