The following data is part of a premarket notification filed by Bk Medical Aps with the FDA for Ultrasound System 1300.
Device ID | K173569 |
510k Number | K173569 |
Device Name: | Ultrasound System 1300 |
Classification | System, Imaging, Pulsed Doppler, Ultrasonic |
Applicant | BK Medical ApS Mileparken 34 Herlev, DK 2730 |
Contact | Karen Provencher |
Correspondent | Karen Provencher BK Medical ApS Mileparken 34 Herlev, DK 2730 |
Product Code | IYN |
Subsequent Product Code | ITX |
Subsequent Product Code | IYO |
CFR Regulation Number | 892.1550 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Abbreviated |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-11-20 |
Decision Date | 2018-02-23 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
05704916001285 | K173569 | 000 |
05704916001698 | K173569 | 000 |
05704916001407 | K173569 | 000 |
05704916001414 | K173569 | 000 |
05704916001421 | K173569 | 000 |
05704916001438 | K173569 | 000 |
05704916001445 | K173569 | 000 |
05704916001513 | K173569 | 000 |
05704916001520 | K173569 | 000 |
05704916001551 | K173569 | 000 |
05704916001568 | K173569 | 000 |
05704916001575 | K173569 | 000 |
05704916001582 | K173569 | 000 |
05704916000325 | K173569 | 000 |
05704916000363 | K173569 | 000 |
05704916000370 | K173569 | 000 |
05704916001667 | K173569 | 000 |