The following data is part of a premarket notification filed by B-k Medical A/s with the FDA for Ultrasound Scanner, Type 2400.
Device ID | K024236 |
510k Number | K024236 |
Device Name: | ULTRASOUND SCANNER, TYPE 2400 |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | B-K MEDICAL A/S MILEPARKEN 34 Herlev, DK Dk-2730 |
Contact | Villy Braender |
Correspondent | Villy Braender B-K MEDICAL A/S MILEPARKEN 34 Herlev, DK Dk-2730 |
Product Code | IYN |
Subsequent Product Code | ITX |
Subsequent Product Code | IYO |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2002-12-23 |
Decision Date | 2003-01-17 |
Summary: | summary |