The following data is part of a premarket notification filed by Zonare Medical Systems, Inc. with the FDA for Zonare Zs3 Diagnostic Ultrasound System.
| Device ID | K151175 |
| 510k Number | K151175 |
| Device Name: | ZONARE ZS3 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 | Special |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2015-05-01 |
| Decision Date | 2015-05-15 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 06944904097756 | K151175 | 000 |
| 06944904092584 | K151175 | 000 |
| 06944904092577 | K151175 | 000 |
| 06944904092560 | K151175 | 000 |
| 06944904092553 | K151175 | 000 |
| 06944904092546 | K151175 | 000 |
| 06944904092539 | K151175 | 000 |
| 06944904092522 | K151175 | 000 |
| 06944904092133 | K151175 | 000 |
| 06944904090757 | K151175 | 000 |
| 06944904090740 | K151175 | 000 |
| 06944904090733 | K151175 | 000 |
| 06944904090719 | K151175 | 000 |
| 06944904092591 | K151175 | 000 |
| 06944904092607 | K151175 | 000 |
| 06944904092614 | K151175 | 000 |
| 06944904097152 | K151175 | 000 |
| 06944904097145 | K151175 | 000 |
| 06944904097138 | K151175 | 000 |
| 06944904097121 | K151175 | 000 |
| 06944904093369 | K151175 | 000 |
| 06944904093352 | K151175 | 000 |
| 06944904093345 | K151175 | 000 |
| 06944904093338 | K151175 | 000 |
| 06944904093321 | K151175 | 000 |
| 06944904093000 | K151175 | 000 |
| 06944904092683 | K151175 | 000 |
| 06944904092621 | K151175 | 000 |
| 05415067013361 | K151175 | 000 |