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 |