The following data is part of a premarket notification filed by Medway with the FDA for Home Amb-alert.
| Device ID | K934344 |
| 510k Number | K934344 |
| Device Name: | HOME AMB-ALERT |
| Classification | Monitor, Bed Patient |
| Applicant | MEDWAY 2176 HILLSBORO RD. SUITE 120-362 Franklin, TN 37064 |
| Contact | James J Callaway |
| Correspondent | James J Callaway MEDWAY 2176 HILLSBORO RD. SUITE 120-362 Franklin, TN 37064 |
| Product Code | KMI |
| CFR Regulation Number | 880.2400 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-09-08 |
| Decision Date | 1994-04-29 |