The following data is part of a premarket notification filed by Homevue Health Systems, Inc. with the FDA for Homevue Wound Monitoring System.
| Device ID | K945807 |
| 510k Number | K945807 |
| Device Name: | HOMEVUE WOUND MONITORING SYSTEM |
| Classification | System, Image Processing, Radiological |
| Applicant | HOMEVUE HEALTH SYSTEMS, INC. 23181 VERDUGO DR. SUITE 101 Laguna Hills, CA 92653 |
| Contact | Steven C Miller |
| Correspondent | Steven C Miller HOMEVUE HEALTH SYSTEMS, INC. 23181 VERDUGO DR. SUITE 101 Laguna Hills, CA 92653 |
| Product Code | LLZ |
| CFR Regulation Number | 892.2050 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-28 |
| Decision Date | 1995-08-07 |