510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K013137Substantially Equivalent

Algo 3 Newborn Hearing Screener

Bio-Logic Systems Corp., San Carlos CA / Special, Substantially Equivalent
FDA source (opens on fda.gov)

K013137 is the FDA 510(k) clearance record for ALGO 3 NEWBORN HEARING SCREENER, a class II device, cleared for Natus Medical, Inc. on under FDA product code GWJ (Stimulator, Auditory, Evoked Response). FDA records list 57 510(k) clearances for Bio-Logic Systems Corp., from to . As of , FDA records show one recall naming K013137.

Clearance record

Decision date
Received
(27 days to decision)
Product code
GWJ Stimulator, Auditory, Evoked Response
Regulation
21 CFR 882.1900
Device class
Class II
Review panel
Neurology
Applicant
Natus Medical, Inc. 1501 Industrial Rd., San Carlos CA
510(k) summary
Summary
Third party review
No

Clearances, product code GWJ

Trailing 12 months

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

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