The following data is part of a premarket notification filed by Zonare Medical Systems, Inc. with the FDA for Zonare Zs3 And Z.onepro Diagnostic Ultrasound System.
Device ID | K150249 |
510k Number | K150249 |
Device Name: | ZONARE ZS3 And Z.Onepro Diagnostic Ultrasound System |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | ZONARE MEDICAL SYSTEMS, INC. 420 NORTH BERNARDO AVENUE Mountain View, CA 94043 |
Contact | Steve Geerdes |
Correspondent | Mark Job REGULATORY TECHNOLOGY SERVICES, LLC 1000 Westgate Drive, Suite 510k Saint Paul, MN 55114 |
Product Code | IYN |
Subsequent Product Code | ITX |
Subsequent Product Code | IYO |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | Yes |
Combination Product | No |
Date Received | 2015-02-03 |
Decision Date | 2015-03-04 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
06944904092690 | K150249 | 000 |
06944904090726 | K150249 | 000 |