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510(k) K960229

RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM by Resound Corp. — Product Code ETW

K960229 is an FDA 510(k) premarket notification submitted by Resound Corp. for the device "RESOUND REAL EAR LOUDNESS MAPPING (RELM) SYSTEM". The FDA issued a decision of Substantially Equivalent on March 7, 1996. The device falls under product code ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems), a Class II device regulated under 21 CFR 874.3310. Resound Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 7, 1996
Date Received
January 17, 1996
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Calibrator, Hearing Aid / Earphone And Analysis Systems
Device Class
Class II
Regulation Number
874.3310
Review Panel
EN
Submission Type

Other clearances by Resound Corp.

  • K984547 — DIGITAL LGOB PROCEDURE USING RESOUND, DIGITAL 5000 SERIES HEARING AIDS (March 19, 1999)
  • K974081 — RESOUND STEALTH CIC (December 12, 1997)
  • K974257 — RESOUND DIGITAL 2000-BT W/DIGITAL 2000-DF (DIGITAL PROGRAMMER) (December 12, 1997)
  • K971605 — RESOUND ED4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (July 3, 1997)
  • K970215 — AUDALLION II HEARING SYSTEM (March 31, 1997)
  • K964557 — RESOUND BT4 PERSONAL HEARING SYSTEM W/REMOTE CONTROL OPTION (November 27, 1996)
  • K964115 — RESOUND CC4 PERSONAL HEARING SYSTEM (November 4, 1996)
  • K960684 — HEARING AID - AIR CONDUCTION (April 10, 1996)
  • K960680 — RESOUND PERSONAL HEARING SYSTEMS EDR ENCORE SERIES MODELS EDR-E, EDR-ES, EDR-EV, (April 10, 1996)
  • K960052 — RESOUND PERSONAL HEARING SYSTEM BT2-ES, BT2-EV, & BT241 (March 12, 1996)

Other clearances for product code ETW

  • K122028 — AURICAL HIT (October 23, 2012)
  • K113831 — PRIMUS HEARING INSTRUMENT TEST UNIT (April 19, 2012)
  • K110286 — GN OTOMETRICS TYPE 1053 FREEFIT (April 28, 2011)
  • K093006 — FONIX ,MODEL 8000 (December 30, 2009)
  • K071462 — UNITY 2 HIA & PROBE ( FOR USE WITH UNITY 2) (June 5, 2007)
  • K061104 — SPEECHLINK 100 TYPE 1053 (May 3, 2006)
  • K050496 — REM440 (April 29, 2005)
  • K041853 — OTOGRAM (September 3, 2004)
  • K022510 — FONIX, MODEL 7000 (August 27, 2002)
  • K012306 — AUDIOSCAN VERIFIT, MODEL VF-1 (September 21, 2001)

FDA data resources