510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K780474Substantially Equivalent

Audiometer Calibrator Model Ra 310

Tracor Instruments, Inc., Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K780474 is the FDA 510(k) clearance record for AUDIOMETER CALIBRATOR MODEL RA 310, a class I device, cleared for Tracor Instruments, Inc. on under FDA product code EWA (Set, Audiometer Calibration). FDA records list 10 510(k) clearances for Tracor Instruments, Inc., from to . As of , FDA records show no recalls naming K780474.

Clearance record

Decision date
Received
(6 days to decision)
Product code
EWA Set, Audiometer Calibration
Regulation
21 CFR 874.1080
Device class
Class I
Review panel
Ear, Nose, Throat
Applicant
Tracor Instruments, Inc. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code EWA

Trailing 12 months

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

FDA records show no clearances under product code EWA in the twelve months to October 2026.
Show the numbers
Monthly 510(k) clearances under FDA product code EWA, 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