FDA 510(k) FDA unclassified Substantially Equivalent 🇺🇸 United States

MINIMUFFS

K Number: K935160 · Decision Feb 9, 1995
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
0
Applicant Total
12
Review Days
468

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Basic Information

Device Name
MINIMUFFS
K Number
K935160
Device Class
FDA unclassified
Clearance Type
Traditional
Medical Specialty
Unknown
Decision
Substantially Equivalent
Statement or Summary
Summary
Applicant
Natus Medical, Inc.
Date Received
October 29, 1993
Decision Date
February 9, 1995
Product Code
EWE
Advisory Committee
Unknown
Review Advisory Committee
EN
Third Party
N

Classifications

This FDA 510(k) entry is associated with 1 FDA classification via its product code.

Product Code Device Name
EWE Protector, Hearing (Circumaural)

Other Clearances by Natus Medical, Inc.

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K083371 NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP)
K073665 ALGO 5 NEWBORN HEARING SCREENER
K051869 NEOBLUE COZY LED PHOTOTHERAPY SYSTEM
K030823 ALGO 3I NEWBORN HEARING SCREENER
K022196 NATUS BLUE LIGHT PHOTOTHERAPY UNIT
K013137 ALGO 3 NEWBORN HEARING SCREENER
K974805 CO-STAT(TM) END TIDAL BREATH ANALYZER
Search all 12 clearances from Natus Medical, Inc. →