The following data is part of a premarket notification filed by Micronica Srl with the FDA for C015.
Device ID | K192182 |
510k Number | K192182 |
Device Name: | C015 |
Classification | Interventional Fluoroscopic X-ray System |
Applicant | Micronica SRL Via Augusto Righi, 30 Mirandola, IT 41037 |
Contact | Massimo Tomasi |
Correspondent | Marisa Testa Thema S.r.l. Via Saragat,5 Imola, IT 40026 |
Product Code | OWB |
Subsequent Product Code | JAA |
Subsequent Product Code | LMC |
Subsequent Product Code | OXO |
CFR Regulation Number | 892.1650 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2019-08-12 |
Decision Date | 2020-01-17 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
08053470960017 | K192182 | 000 |
08053470960000 | K192182 | 000 |