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510(k) K861113

ER-7C CLINICAL PROBE MICROPHONE by Etymotic Research — Product Code ETW

K861113 is an FDA 510(k) premarket notification submitted by Etymotic Research for the device "ER-7C CLINICAL PROBE MICROPHONE". The FDA issued a decision of Substantially Equivalent on April 23, 1986. The device falls under product code ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems), a Class II device regulated under 21 CFR 874.3310. Etymotic Research has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
April 23, 1986
Date Received
March 25, 1986
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 Etymotic Research

  • K150491 — ER36 Series OAE Test System (March 26, 2015)
  • K112733 — ER35 ERO-SCAN PRO HEARING TEST SYSTEM (December 16, 2011)
  • K070880 — ER35 ERO-SCAN PRO HEARING TEST SYSTEM (June 7, 2007)
  • K011114 — ETYMOTIC RESEARCH ER-10D OAE PROBE (July 3, 2001)
  • K010165 — ERO SCAN OAE TEST SYSTEM (March 12, 2001)
  • K980533 — ERO-SCAN OTOACOUSTIC EMISSIONS TEST INST. (ER34) (March 23, 1998)
  • K930553 — CUB DIS OTOACOUSTIC EMISSIONS TEST INSTRUMENT (September 29, 1993)
  • K930003 — TUBEPHONE MODELS ER-3A & ER-3 INSERT EARPHONES (June 18, 1993)
  • K873298 — ELEC-TIP (November 24, 1987)
  • K843144 — K-BASS LO FREQUENCY HEARING AID (September 7, 1984)

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