The following data is part of a premarket notification filed by Innovia Medical, Llc with the FDA for Earcheck Acoustic Reflectometer.
| Device ID | K070312 |
| 510k Number | K070312 |
| Device Name: | EARCHECK ACOUSTIC REFLECTOMETER |
| Classification | Tester, Auditory Impedance |
| Applicant | INNOVIA MEDICAL, LLC 13 RED FOX LANE Littleton, CO 80127 |
| Contact | Kevin Walls |
| Correspondent | Kevin Walls INNOVIA MEDICAL, LLC 13 RED FOX LANE Littleton, CO 80127 |
| Product Code | ETY |
| CFR Regulation Number | 874.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2007-02-01 |
| Decision Date | 2007-03-02 |