The following data is part of a premarket notification filed by Thd Spa with the FDA for Thd Procto Software System.
Device ID | K211623 |
510k Number | K211623 |
Device Name: | THD Procto Software System |
Classification | System, Imaging, Pulsed Echo, Ultrasonic |
Applicant | THD SpA Via Dell'Industria, 1 Correggio, IT 42015 |
Contact | Maurizio Pantaleoni |
Correspondent | Maurizio Pantaleoni THD SpA Via Dell'Industria, 1 Correggio, IT 42015 |
Product Code | IYO |
Subsequent Product Code | FWG |
Subsequent Product Code | ITX |
Subsequent Product Code | KLA |
Subsequent Product Code | NSX |
Subsequent Product Code | OUG |
CFR Regulation Number | 892.1560 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Special |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 2021-05-26 |
Decision Date | 2021-06-24 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
18033737712389 | K211623 | 000 |
08033737713037 | K211623 | 000 |
58051887042642 | K211623 | 000 |
18033737712341 | K211623 | 000 |
68051887043325 | K211623 | 000 |
68051887043318 | K211623 | 000 |
68051887043301 | K211623 | 000 |
68051887043295 | K211623 | 000 |