The following data is part of a premarket notification filed by Silent Call Corp. with the FDA for Med-a-call Assist Device.
| Device ID | K890596 |
| 510k Number | K890596 |
| Device Name: | MED-A-CALL ASSIST DEVICE |
| Classification | System, Environmental Control, Powered |
| Applicant | SILENT CALL CORP. P.O. BOX 16348 Clarkston, MI 48016 -6348 |
| Contact | George J Elwell |
| Correspondent | George J Elwell SILENT CALL CORP. P.O. BOX 16348 Clarkston, MI 48016 -6348 |
| Product Code | IQA |
| CFR Regulation Number | 890.3725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1989-01-27 |
| Decision Date | 1989-03-14 |