The following data is part of a premarket notification filed by Inventis Srl with the FDA for Inventis Middle Ear Analyzer, Flute Basic, Inventis Middle Ear Analyzer, Flute Plus, Inventis Middle Ear Analyzer, Flute.
| Device ID | K133013 |
| 510k Number | K133013 |
| Device Name: | INVENTIS MIDDLE EAR ANALYZER, FLUTE BASIC, INVENTIS MIDDLE EAR ANALYZER, FLUTE PLUS, INVENTIS MIDDLE EAR ANALYZER, FLUTE |
| Classification | Tester, Auditory Impedance |
| Applicant | INVENTIS SRL CORSO STATI UNITI 1/3 Padova, IT 35127 |
| Contact | Massimo Martinelli |
| Correspondent | Massimo Martinelli INVENTIS SRL CORSO STATI UNITI 1/3 Padova, IT 35127 |
| Product Code | ETY |
| CFR Regulation Number | 874.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-09-25 |
| Decision Date | 2014-01-24 |
| Summary: | summary |