The following data is part of a premarket notification filed by Atl Ultrasound, Inc. with the FDA for Hdi 5000 Ultrasound System With Extended Field Of View Imaging.
| Device ID | K002003 |
| 510k Number | K002003 |
| Device Name: | HDI 5000 ULTRASOUND SYSTEM WITH EXTENDED FIELD OF VIEW IMAGING |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ATL ULTRASOUND, INC. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Contact | Terrence J Sweeney |
| Correspondent | Carole Stamp TUV PRODUCT SERVICE, INC. 1775 OLD HIGHWAY 8 New Brighton, MN 55112 -1891 |
| 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 | 2000-06-30 |
| Decision Date | 2000-07-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00884838068063 | K002003 | 000 |