The following data is part of a premarket notification filed by Amplaid with the FDA for Amplaid A756 Screening Admittance Meter.
| Device ID | K031978 |
| 510k Number | K031978 |
| Device Name: | AMPLAID A756 SCREENING ADMITTANCE METER |
| Classification | Tester, Auditory Impedance |
| Applicant | AMPLAID PO BOX 7007 Deerfield, IL 60015 |
| Contact | Daniel Kamm |
| Correspondent | Daniel Kamm AMPLAID PO BOX 7007 Deerfield, IL 60015 |
| Product Code | ETY |
| CFR Regulation Number | 874.1090 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-06-26 |
| Decision Date | 2003-07-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 08051597160099 | K031978 | 000 |
| 08051597160051 | K031978 | 000 |