510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K830173Substantially Equivalent

Bera Sh 221 Brian Stem Audiometer

JEDMED Instrument Company, Mchenry IL / Traditional, Substantially Equivalent
FDA source (opens on fda.gov)

K830173 is the FDA 510(k) clearance record for BERA SH 221 BRIAN STEM AUDIOMETER, a class I device, cleared for Jedmed Instrument Co. on under FDA product code GNJ (Antigens, Ha, Echovirus 1-34). FDA records list 93 510(k) clearances for Jedmed Instrument Co., from to . As of , FDA records show no recalls naming K830173.

Clearance record

Decision date
Received
(127 days to decision)
Product code
GNJ Antigens, Ha, Echovirus 1-34
Regulation
21 CFR 866.3205
Device class
Class I
Review panel
Microbiology
Applicant
Jedmed Instrument Co. 803 N. Front St. Suite 3, Mchenry IL
Third party review
No

Clearances, product code GNJ

Trailing 12 months

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

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