510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K812952Substantially Equivalent

Rion Audiometer Aa-68

Rion Acoustic Instruments, Inc., Walker MI / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K812952 is the FDA 510(k) clearance record for RION AUDIOMETER AA-68, a class II device, cleared for Rion Acoustic Instruments, Inc. on under FDA product code GWO (Plate, Cranioplasty, Preformed, Alterable). FDA records list 51 510(k) clearances for Rion Acoustic Instruments, Inc., from to . As of , FDA records show no recalls naming K812952.

Clearance record

Decision date
Received
(16 days to decision)
Product code
GWO Plate, Cranioplasty, Preformed, Alterable
Regulation
21 CFR 882.5320
Device class
Class II
Review panel
Neurology
Applicant
Rion Acoustic Instruments, Inc. 4221 Richmond Rd., NW, Walker MI
Third party review
No

Clearances, product code GWO

Trailing 12 months
2 clearances under product code GWO in the twelve months to October 2026, July 2026 the highest month at 1.
Show the numbers
Monthly 510(k) clearances under FDA product code GWO, trailing twelve months
MonthClearances
November 20250
December 20250
January 20260
February 20260
March 20260
April 20260
May 20260
June 20260
July 20261
August 20260
September 20261
October 20260