The following data is part of a premarket notification filed by Philips Ultrasound, Inc. with the FDA for Hd15 Diagnostic Ultrasound System.
| Device ID | K081661 |
| 510k Number | K081661 |
| Device Name: | HD15 DIAGNOSTIC ULTRASOUND SYSTEM |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | PHILIPS ULTRASOUND, INC. 22100 BOTHELL EVERETT HWY. Bothell, WA 98021 |
| 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 | 2008-06-13 |
| Decision Date | 2008-06-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838067943 | K081661 | 000 |
| 00884838064638 | K081661 | 000 |
| 00884838064591 | K081661 | 000 |
| 00884838061804 | K081661 | 000 |
| 00884838025233 | K081661 | 000 |