The following data is part of a premarket notification filed by International Biomedics, Inc. with the FDA for Fetascan 1500.
| Device ID | K860295 |
| 510k Number | K860295 |
| Device Name: | FETASCAN 1500 |
| Classification | System, Monitoring, Perinatal |
| Applicant | INTERNATIONAL BIOMEDICS, INC. 1631 220TH AVE. S.E. (PER DO, FIRM OOB) Bothell, WA 98021 |
| Contact | Howard M Hochberg |
| Correspondent | Howard M Hochberg INTERNATIONAL BIOMEDICS, INC. 1631 220TH AVE. S.E. (PER DO, FIRM OOB) Bothell, WA 98021 |
| Product Code | HGM |
| CFR Regulation Number | 884.2740 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-01-28 |
| Decision Date | 1986-05-19 |