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 |