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 |