The following data is part of a premarket notification filed by Biomedics with the FDA for Biomedics Bladder Scanner.
| Device ID | K842687 |
| 510k Number | K842687 |
| Device Name: | BIOMEDICS BLADDER SCANNER |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | BIOMEDICS P.O. BOX 971 Mercer Island , WA 98040 - |
| Contact | Howard M Hochberg |
| Correspondent | Howard M Hochberg BIOMEDICS P.O. BOX 971 Mercer Island , WA 98040 - |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-10 |
| Decision Date | 1985-04-08 |