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 |