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510(k) K853271

HEARING AID ANALYSIS SYSTEM by Robert Bosch Corp. — Product Code ETW

K853271 is an FDA 510(k) premarket notification submitted by Robert Bosch Corp. for the device "HEARING AID ANALYSIS SYSTEM". The FDA issued a decision of Substantially Equivalent on January 16, 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. Robert Bosch Corp. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1986
Date Received
August 5, 1985
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 Robert Bosch Corp.

  • K854492 — ERG 551 ERGOMETER, BICYCLE (June 16, 1986)
  • K854491 — ERG 550 ERGOMETER BICYCLE (June 16, 1986)
  • K854493 — ERG 555 COUCH ERGOMETER (June 16, 1986)
  • K853154 — HV-4 (March 28, 1986)
  • K853541 — SP 4 (March 28, 1986)
  • K851485 — DEFI 502 (August 29, 1985)
  • K840717 — ECS 502 (August 19, 1985)
  • K851937 — SONOMED 4 (July 17, 1985)
  • K850188 — BOSCH IN THE EAR HEARING AID SUPERSTAR (April 9, 1985)
  • K850186 — POST AURICULAR HEARING AIDS STAR 33PP, 44,55F & (March 27, 1985)

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