The following data is part of a premarket notification filed by Telemed with the FDA for Micrus.
Device ID | K161968 |
510k Number | K161968 |
Device Name: | MicrUs |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | TELEMED Dariaus Ir Gireno Str.42 Vilnius, LT Lt-02189 |
Contact | Yury Sokolov |
Correspondent | Yury Sokolov Medical Imaging Innovations Dariaus Ir Gireno Str. 42 Vilnius, LT |
Product Code | IYO |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2016-07-18 |
Decision Date | 2016-11-03 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04772057000147 | K161968 | 000 |
04772057000130 | K161968 | 000 |
04772057000123 | K161968 | 000 |
04772057000116 | K161968 | 000 |
04772057000109 | K161968 | 000 |
04772057000352 | K161968 | 000 |
04772057000345 | K161968 | 000 |
04772057000338 | K161968 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
![]() MICRUS 75210504 2527722 Dead/Cancelled |
DEPUY SYNTHES, INC. 1996-11-29 |
![]() MICRUS 75161438 not registered Dead/Abandoned |
ALOKA CO., LTD. 1996-09-05 |
![]() MICRUS 74569686 2063680 Dead/Cancelled |
MICRUS HOLDINGS INC. 1994-09-06 |