The following data is part of a premarket notification filed by Interspec, Inc. with the FDA for Ultrasonic Imaging System (modified).
Device ID | K860568 |
510k Number | K860568 |
Device Name: | ULTRASONIC IMAGING SYSTEM (MODIFIED) |
Classification | Transducer, Ultrasonic, Diagnostic |
Applicant | INTERSPEC, INC. 1100 E. HECTOR ST. Conshohocken, PA 19428 |
Contact | Bernardi Phd |
Correspondent | Bernardi Phd INTERSPEC, INC. 1100 E. HECTOR ST. Conshohocken, PA 19428 |
Product Code | ITX |
CFR Regulation Number | 892.1570 [🔎] |
Decision | Substantially Equivalent For Some Indications (SN) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-14 |
Decision Date | 1986-08-11 |