The following data is part of a premarket notification filed by B-k Medical Aps with the FDA for Needle Guide For 8814, Model Ua1335, Needle Guide For 8815, Model Ua 1336, Needle Guide For 8824, Model Ua 1337.
| Device ID | K083667 |
| 510k Number | K083667 |
| Device Name: | NEEDLE GUIDE FOR 8814, MODEL UA1335, NEEDLE GUIDE FOR 8815, MODEL UA 1336, NEEDLE GUIDE FOR 8824, MODEL UA 1337 |
| Classification | Transducer, Ultrasonic, Diagnostic |
| Applicant | B-K MEDICAL APS MILEPARKEN 34 Herlev, DK Dk-2730 |
| Contact | Lars Oksby Hansen |
| Correspondent | Lars Oksby Hansen B-K MEDICAL APS MILEPARKEN 34 Herlev, DK Dk-2730 |
| Product Code | ITX |
| CFR Regulation Number | 892.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-12-11 |
| Decision Date | 2009-02-02 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 05704916001018 | K083667 | 000 |
| 05704916000998 | K083667 | 000 |
| 05704916000875 | K083667 | 000 |
| 05704916000851 | K083667 | 000 |
| 05704916000837 | K083667 | 000 |
| 05704916000813 | K083667 | 000 |