The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Epiq Diagnostic Ultrasound System.
| Device ID | K132304 |
| 510k Number | K132304 |
| Device Name: | EPIQ DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | PHILIPS ULTRASOUND, INC. 22100 BOTHELL EVERETT HWY. Bothell, WA 98021 |
| Contact | Jessica Stenberg |
| 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 | 2013-07-24 |
| Decision Date | 2013-08-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838067837 | K132304 | 000 |
| 00884838047693 | K132304 | 000 |
| 00884838056244 | K132304 | 000 |
| 00884838056251 | K132304 | 000 |
| 00884838061422 | K132304 | 000 |
| 00884838061446 | K132304 | 000 |
| 00884838061507 | K132304 | 000 |
| 00884838061545 | K132304 | 000 |
| 00884838061552 | K132304 | 000 |
| 00884838061576 | K132304 | 000 |
| 00884838061590 | K132304 | 000 |
| 00884838061606 | K132304 | 000 |
| 00884838061644 | K132304 | 000 |
| 00884838061651 | K132304 | 000 |
| 00884838047686 | K132304 | 000 |