The following data is part of a premarket notification filed by Elekta Instrument Ab with the FDA for Leksell Vantage Stereotactic System.
Device ID | K171123 |
510k Number | K171123 |
Device Name: | Leksell Vantage Stereotactic System |
Classification | Neurological Stereotaxic Instrument |
Applicant | Elekta Instrument AB Kungstensgatan 18 Stockholm, SE 10393 |
Contact | Matilda Forsberg |
Correspondent | Matilda Forsberg 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 | 2017-04-17 |
Decision Date | 2017-09-15 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
07340048311892 | K171123 | 000 |
07340048304368 | K171123 | 000 |
07340048304375 | K171123 | 000 |
07340048304382 | K171123 | 000 |
07340048304399 | K171123 | 000 |
07340048304405 | K171123 | 000 |
07340048304412 | K171123 | 000 |
07340048304658 | K171123 | 000 |
07340048304665 | K171123 | 000 |
07340048304351 | K171123 | 000 |
07340048304344 | K171123 | 000 |
07340048304207 | K171123 | 000 |
07340048304214 | K171123 | 000 |
07340048304238 | K171123 | 000 |
07340048304252 | K171123 | 000 |
07340048304276 | K171123 | 000 |
07340048304290 | K171123 | 000 |
07340048311342 | K171123 | 000 |
07340048304337 | K171123 | 000 |
07340048304672 | K171123 | 000 |
07340048304689 | K171123 | 000 |
07340048304696 | K171123 | 000 |
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07340048304863 | K171123 | 000 |
07340048304870 | K171123 | 000 |
07340048304887 | K171123 | 000 |
07340048305167 | K171123 | 000 |
07340048311151 | K171123 | 000 |
07340048311281 | K171123 | 000 |
07340048304832 | K171123 | 000 |
07340048304825 | K171123 | 000 |
07340048304702 | K171123 | 000 |
07340048304719 | K171123 | 000 |
07340048304726 | K171123 | 000 |
07340048304757 | K171123 | 000 |
07340048304788 | K171123 | 000 |
07340048304795 | K171123 | 000 |
07340048304801 | K171123 | 000 |
07340048304818 | K171123 | 000 |
07340048311335 | K171123 | 000 |