510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K183201Substantially Equivalent

Hearing Healthcare Pro

Db Diagnostic Systems, Inc., Weston CT / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)510(k) summary (opens on fda.gov)

K183201 is the FDA 510(k) clearance record for Hearing Healthcare Pro, a class II device, cleared for Db Diagnostic Systems, Inc. on under FDA product code ETY (Tester, Auditory Impedance). FDA records list 2 510(k) clearances for Db Diagnostic Systems, Inc., from to . As of , FDA records show no recalls naming K183201.

Clearance record

Decision date
Received
(107 days to decision)
Product code
ETY Tester, Auditory Impedance
Regulation
21 CFR 874.1090
Device class
Class II
Review panel
Ear, Nose, Throat
Applicant
Db Diagnostic Systems, Inc. 17 Sachem Rd., Weston CT
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