The following data is part of a premarket notification filed by Bartronix with the FDA for Bartronix In-bed Activity Monitor.
| Device ID | K914859 |
| 510k Number | K914859 |
| Device Name: | BARTRONIX IN-BED ACTIVITY MONITOR |
| Classification | Monitor, Bed Patient |
| Applicant | BARTRONIX 7304 BRISTLECONE CT. Fort Worth, TX 76137 |
| Contact | Irta Hudgins |
| Correspondent | Irta Hudgins BARTRONIX 7304 BRISTLECONE CT. Fort Worth, TX 76137 |
| Product Code | KMI |
| CFR Regulation Number | 880.2400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-10-29 |
| Decision Date | 1992-04-13 |