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 |