The following data is part of a premarket notification filed by International Biomedics, Inc. with the FDA for Fetascan Ultrasound Transducer Ibi# 101b00054-01.
| Device ID | K862072 |
| 510k Number | K862072 |
| Device Name: | FETASCAN ULTRASOUND TRANSDUCER IBI# 101B00054-01 |
| Classification | Transducer, Ultrasonic, Obstetric |
| Applicant | INTERNATIONAL BIOMEDICS, INC. 1631 220TH AVE. S.E. (PER DO, FIRM OOB) Bothell, WA 98021 |
| Contact | Hochberg, Md |
| Correspondent | Hochberg, Md INTERNATIONAL BIOMEDICS, INC. 1631 220TH AVE. S.E. (PER DO, FIRM OOB) Bothell, WA 98021 |
| Product Code | HGL |
| CFR Regulation Number | 884.2960 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-05-30 |
| Decision Date | 1986-07-09 |