The following data is part of a premarket notification filed by Acuson Corp. with the FDA for Aspen Ultrasound With Freestyle Imaging Option.
| Device ID | K991805 |
| 510k Number | K991805 |
| Device Name: | ASPEN ULTRASOUND WITH FREESTYLE IMAGING OPTION |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | ACUSON CORP. 1220 CHARLESTON RD. Mountain View, CA 94039 -7393 |
| Contact | William Welch |
| Correspondent | William Welch ACUSON CORP. 1220 CHARLESTON RD. Mountain View, CA 94039 -7393 |
| 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 | No |
| Combination Product | No |
| Date Received | 1999-05-26 |
| Decision Date | 1999-08-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04056869005218 | K991805 | 000 |
| 04056869005188 | K991805 | 000 |
| 04056869005058 | K991805 | 000 |
| 04056869005041 | K991805 | 000 |
| 04056869005034 | K991805 | 000 |