The following data is part of a premarket notification filed by Amplaid Usa, Inc. with the FDA for Self-recording Admittance Meter 709.
| Device ID | K802097 |
| 510k Number | K802097 |
| Device Name: | SELF-RECORDING ADMITTANCE METER 709 |
| Classification | Tester, Auditory Impedance |
| Applicant | AMPLAID USA, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | ETY |
| CFR Regulation Number | 874.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-02 |
| Decision Date | 1980-10-10 |