The following data is part of a premarket notification filed by Bruel & Kjaer with the FDA for Diagnostic Ultrasound System Type 3535.
| Device ID | K905198 |
| 510k Number | K905198 |
| Device Name: | DIAGNOSTIC ULTRASOUND SYSTEM TYPE 3535 |
| Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
| Applicant | BRUEL & KJAER 18 NAERUM HOVEDGODE Naerum 2850, DK |
| Contact | Aage Ruby |
| Correspondent | Aage Ruby BRUEL & KJAER 18 NAERUM HOVEDGODE Naerum 2850, DK |
| Product Code | IYN |
| CFR Regulation Number | 892.1550 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-11-20 |
| Decision Date | 1991-08-28 |