The following data is part of a premarket notification filed by Homevue Health Systems, Inc. with the FDA for Homevue Monitoring Sys.model Td 2000.
| Device ID | K912138 |
| 510k Number | K912138 |
| Device Name: | HOMEVUE MONITORING SYS.MODEL TD 2000 |
| Classification | System, Monitoring, Perinatal |
| Applicant | HOMEVUE HEALTH SYSTEMS, INC. 673 MYSTIC WAY Laguna Beach, CA 92651 |
| Contact | Gary R.mounts |
| Correspondent | Gary R.mounts HOMEVUE HEALTH SYSTEMS, INC. 673 MYSTIC WAY Laguna Beach, CA 92651 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-14 |
| Decision Date | 1992-03-19 |