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510(k) K012384

EAR MUFFINS by Bio-Logic Systems Corp. — Product Code HCC

K012384 is an FDA 510(k) premarket notification submitted by Bio-Logic Systems Corp. for the device "EAR MUFFINS". The FDA issued a decision of Substantially Equivalent on October 15, 2001. The device falls under product code HCC (Device, Biofeedback), a Class II device regulated under 21 CFR 882.5050. Bio-Logic Systems Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
October 15, 2001
Date Received
July 27, 2001
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Device, Biofeedback
Device Class
Class II
Regulation Number
882.5050
Review Panel
NE
Submission Type

Other clearances by Bio-Logic Systems Corp.

  • K122496 — AUDX PRO OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM (November 1, 2012)
  • K121512 — SCOUT SPORT OTOACOUSTIC EMISSIONS MEASUREMENT SYSTEM (July 26, 2012)
  • K073626 — BIO-LOGIC MASTER II EVOKED RESPONSE SYSTEM (February 5, 2008)
  • K061744 — COCHLEA-SCAN / COCHLEA-SCAN PLUS (September 15, 2006)
  • K052066 — CEEGRAPH/SLEEPSCAN NETLINK TRAVELER (August 26, 2005)
  • K031352 — BIO-LOGIC INSERT EARPHONES (July 16, 2003)
  • K030907 — STACKED ABR FOR NAVIGATOR PRO (May 9, 2003)
  • K031009 — MODIFICATION TO BIO-LOGIC EVOKED POTENTIAL (EP) SYSTEM (April 28, 2003)
  • K021895 — BIO-LOGIC MASTER EVOKED RESPONSE SYSTEM (July 1, 2002)
  • K021801 — BIO-LOGIC ABAER CUB WITH INTEGRATED OAE & ABR FUNCTIONS (June 27, 2002)

Other clearances for product code HCC

  • K233580 — A Breathing System (ABS) (August 1, 2024)
  • K222101 — Prism (March 17, 2023)
  • K180173 — Freespira (August 23, 2018)
  • K163448 — GrindCare System (September 1, 2017)
  • K151050 — Pacifier Activated Lullaby (PAL®) (December 22, 2015)
  • K143507 — NFANT Feeding Solution (September 9, 2015)
  • K131586 — CANARY BREATHING SYSTEM (December 10, 2013)
  • K122879 — EEGER4 MODEL 4.3 (February 6, 2013)
  • K111687 — EMG SYSTEM (September 29, 2011)
  • K092675 — GRINDCARE (March 3, 2010)

FDA data resources