Home / 510(k) Clearances / K935160

510(k) K935160

MINIMUFFS by Natus Medical, Inc. — Product Code EWE

K935160 is an FDA 510(k) premarket notification submitted by Natus Medical, Inc. for the device "MINIMUFFS". The FDA issued a decision of Substantially Equivalent on February 9, 1995. The device falls under product code EWE (Protector, Hearing (Circumaural)), a Class U device. Natus Medical, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
February 9, 1995
Date Received
October 29, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protector, Hearing (Circumaural)
Device Class
Class U
Regulation Number
Review Panel
EN
Submission Type

Other clearances by Natus Medical, Inc.

  • K093304 — PROTEKTOR 32 (August 11, 2010)
  • K093949 — OLYMPIC BRAINZ MONITOR MODEL OBM70001 (June 16, 2010)
  • K090019 — NATUS NEUROWORKS, MODEL 104196 (February 22, 2010)
  • K083371 — NAVIGATOR PRO WITH AEP SOFTWARE (BIOMARK, ENOG, CHAMP) (December 8, 2009)
  • K073665 — ALGO 5 NEWBORN HEARING SCREENER (January 25, 2008)
  • K051869 — NEOBLUE COZY LED PHOTOTHERAPY SYSTEM (October 7, 2005)
  • K030823 — ALGO 3I NEWBORN HEARING SCREENER (April 9, 2003)
  • K022196 — NATUS BLUE LIGHT PHOTOTHERAPY UNIT (September 19, 2002)
  • K013137 — ALGO 3 NEWBORN HEARING SCREENER (October 16, 2001)
  • K974805 — CO-STAT(TM) END TIDAL BREATH ANALYZER (March 11, 1998)

FDA data resources