The following data is part of a premarket notification filed by Atl Ultrasound, Inc. with the FDA for Hdi 1500/sa 8800 Ultrasound System With Multiplane Transesophageal Ultrasound Transducer (mtp7-4).
| Device ID | K994373 |
| 510k Number | K994373 |
| Device Name: | HDI 1500/SA 8800 ULTRASOUND SYSTEM WITH MULTIPLANE TRANSESOPHAGEAL ULTRASOUND TRANSDUCER (MTP7-4) |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | ATL ULTRASOUND, INC. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Contact | Terrance J Sweeeney |
| Correspondent | Terrance J Sweeeney ATL ULTRASOUND, INC. P.O. BOX 3003 Bothell, WA 98041 -3003 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-27 |
| Decision Date | 2000-03-24 |
| Summary: | summary |