The following data is part of a premarket notification filed by Medway with the FDA for Amb-alert.
| Device ID | K911079 |
| 510k Number | K911079 |
| Device Name: | 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 | 1991-03-11 |
| Decision Date | 1991-09-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() AMB-ALERT 74487407 1897438 Dead/Cancelled |
MEDWAY, INC. 1994-02-07 |
![]() AMB-ALERT 74149869 not registered Dead/Abandoned |
MEDWAY, INC. 1991-03-21 |