The following data is part of a premarket notification filed by Idmed with the FDA for Tofscan.
Device ID | K172690 |
510k Number | K172690 |
Device Name: | ToFscan |
Classification | Stimulator, Nerve, Peripheral, Electric |
Applicant | Idmed Hotel Technoptic - 2 Rue Marc Donadille Marseille, FR 13013 |
Contact | Frédéric Bernert |
Correspondent | Frédéric Bernert Idmed Hotel Technoptic - 2 Rue Marc Donadille Marseille, FR 13013 |
Product Code | KOI |
CFR Regulation Number | 868.2775 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2017-09-06 |
Decision Date | 2018-05-31 |
Summary: | summary |
Device Identifier | submissionNumber | Supplement |
---|---|---|
03665023000450 | K172690 | 000 |
03665023000122 | K172690 | 000 |
03665023000153 | K172690 | 000 |
03665023000344 | K172690 | 000 |
03665023000047 | K172690 | 000 |
03665023000078 | K172690 | 000 |
03665023000368 | K172690 | 000 |
03665023000375 | K172690 | 000 |
03665023000597 | K172690 | 000 |
03665023000351 | K172690 | 000 |
03665023000054 | K172690 | 000 |
03665023000467 | K172690 | 000 |
03665023000474 | K172690 | 000 |
03665023000481 | K172690 | 000 |
03665023000498 | K172690 | 000 |
03665023000504 | K172690 | 000 |
03665023000511 | K172690 | 000 |
03665023000061 | K172690 | 000 |
03665023000030 | K172690 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
TOFSCAN 79122216 not registered Dead/Abandoned |
IDMED 2012-10-23 |