510(K) CLEARANCES 75 ▼9RECALLS POSTED 26 ▼13CLASS I 2 ▼4PMA DECISIONS 54 ▲7WEEK ENDING / FDA DATA AS OF
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K031978Substantially Equivalent

Amplaid A756 Screening Admittance Meter

Amplaid, Deer Field IL / Special, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K031978 is the FDA 510(k) clearance record for AMPLAID A756 SCREENING ADMITTANCE METER, a class II device, cleared for Amplaid on under FDA product code ETY (Tester, Auditory Impedance). FDA records list one 510(k) clearance for Amplaid. As of , FDA records show no recalls naming K031978.

Clearance record

Decision date
Received
(25 days to decision)
Product code
ETY Tester, Auditory Impedance
Regulation
21 CFR 874.1090
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Amplaid P.O. Box 7007, Deer Field IL
510(k) summary
Summary PDF
Third party review
No

Clearances, product code ETY

Trailing 12 months

FDA records hold no clearances under product code ETY in the trailing twelve months.

FDA records show no clearances under product code ETY in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code ETY, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20260
August 20260
September 20260
October 20260