The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Leksell Vantage Stereotactic System.
Device ID | K190887 |
510k Number | K190887 |
Device Name: | Leksell Vantage Stereotactic System |
Classification | Neurological Stereotaxic Instrument |
Applicant | Elekta Instrument AB Kungstensgatan 18 Stockholm, SE 10393 |
Contact | Helena Skar |
Correspondent | Alf Laurell Elekta Instrument AB Kungstensgatan 18 Stockholm, SE 10393 |
Product Code | HAW |
CFR Regulation Number | 882.4560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-04-04 |
Decision Date | 2019-08-01 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07340048311625 | K190887 | 000 |
07340201501276 | K190887 | 000 |
07340201501252 | K190887 | 000 |
07340201501313 | K190887 | 000 |
07340201501290 | K190887 | 000 |
07340201501337 | K190887 | 000 |
07340201501887 | K190887 | 000 |
07340201501511 | K190887 | 000 |
07340201502129 | K190887 | 000 |
07340201501504 | K190887 | 000 |
07340201501382 | K190887 | 000 |
07340201501634 | K190887 | 000 |
07340201501658 | K190887 | 000 |
07340048311601 | K190887 | 000 |
07340048311472 | K190887 | 000 |
07340048311458 | K190887 | 000 |
07340048311373 | K190887 | 000 |
07340201501764 | K190887 | 000 |
07340201502198 | K190887 | 000 |
07340201501825 | K190887 | 000 |
07340201501757 | K190887 | 000 |
07340201501719 | K190887 | 000 |
07340201501528 | K190887 | 000 |