The following data is part of a premarket notification filed by International Biomedics, Inc. with the FDA for Feta Scan 1000 Obstetrical Imager.
| Device ID | K852439 |
| 510k Number | K852439 |
| Device Name: | FETA SCAN 1000 OBSTETRICAL IMAGER |
| Classification | Imager, Ultrasonic Obstetric-gynecologic |
| Applicant | INTERNATIONAL BIOMEDICS, INC. P.O. BOX 971 Mercer Island, WA 98040 |
| Contact | Howard M Hochberg |
| Correspondent | Howard M Hochberg INTERNATIONAL BIOMEDICS, INC. P.O. BOX 971 Mercer Island, WA 98040 |
| Product Code | HEM |
| CFR Regulation Number | 884.2225 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-06-10 |
| Decision Date | 1985-08-30 |