510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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K935160Substantially Equivalent

Minimuffs

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

K935160 is the FDA 510(k) clearance record for MINIMUFFS, cleared for Natus Medical, Inc. on under FDA product code EWE (Protector, Hearing (Circumaural)). FDA records list 57 510(k) clearances for Bio-Logic Systems Corp., from to . As of , FDA records show no recalls naming K935160.

Clearance record

Decision date
Received
(468 days to decision)
Product code
EWE Protector, Hearing (Circumaural)
Device class
Unclassified
Review panel
Unknown
Applicant
Natus Medical, Inc. 1501 Industrial Rd., San Carlos CA
510(k) summary
Summary
Third party review
No

Clearances, product code EWE

Trailing 12 months

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

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