The following data is part of a premarket notification filed by Ausonics Pty Ltd. with the FDA for 7.5 Mhz Short Focus Fluid Offset Probe #041-726t.
Device ID | K860494 |
510k Number | K860494 |
Device Name: | 7.5 MHZ SHORT FOCUS FLUID OFFSET PROBE #041-726T |
Classification | Transducer, Ultrasonic, Diagnostic |
Applicant | AUSONICS PTY LTD. 40 CRANE HILL RD. Suffield, CT 06078 |
Contact | William C Nealon |
Correspondent | William C Nealon AUSONICS PTY LTD. 40 CRANE HILL RD. Suffield, CT 06078 |
Product Code | ITX |
CFR Regulation Number | 892.1570 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1986-02-10 |
Decision Date | 1986-03-26 |