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510(k) K970324

GSI SA60 DPOAE SYSTEM by Grason-Stadler, Inc. — Product Code ETW

K970324 is an FDA 510(k) premarket notification submitted by Grason-Stadler, Inc. for the device "GSI SA60 DPOAE SYSTEM". The FDA issued a decision of Substantially Equivalent on June 6, 1997. The device falls under product code ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems), a Class II device regulated under 21 CFR 874.3310. Grason-Stadler, Inc. has at least 10 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
June 6, 1997
Date Received
January 27, 1997
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 Grason-Stadler, Inc.

  • K180287 — GSI Corti (May 11, 2018)
  • K172403 — GSI Novus (October 20, 2017)
  • K000097 — GSI 2000 MIDDLE EAR ANALYZER (April 12, 2000)
  • K974237 — GSI 70 AUDIOPATH SCREENER (February 10, 1998)
  • K953684 — GSI 61 CLINICAL AUDIOMETER (October 27, 1995)
  • K951759 — GSI 65 COMPUTERIZED AUDIOMETER (July 6, 1995)
  • K902540 — GSI 17 SCREENING AUDIOMETER (July 13, 1990)
  • K890124 — ILO88 OTODYNAMIC ANALYZER SCREENING AUDIOMETER (July 14, 1989)
  • K870030 — THE SCREENER GSI 55 ABR SCREENER (March 13, 1987)
  • K863353 — MIDDLE EAR ANALYZER (IMPEDANCE AUDIOMETER) (November 3, 1986)

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