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510(k) K896301

MODEL 340 PROBE MIC SYSTEM by Virtual Corp. — Product Code ETW

K896301 is an FDA 510(k) premarket notification submitted by Virtual Corp. for the device "MODEL 340 PROBE MIC SYSTEM". The FDA issued a decision of Substantially Equivalent on January 16, 1990. The device falls under product code ETW (Calibrator, Hearing Aid / Earphone And Analysis Systems), a Class II device regulated under 21 CFR 874.3310. Virtual Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
January 16, 1990
Date Received
October 30, 1989
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 Virtual Corp.

  • K960500 — THE VIRTUAL M-332 (April 3, 1996)
  • K934715 — MODEL 222 CLINICAL AUDIOMETER (May 10, 1994)
  • K930203 — MODEL 322 CLINICAL AUDIOMETER (July 8, 1993)
  • K926574 — MODEL 330 SCREENING AUDIO METER, MODIFIED (March 29, 1993)
  • K911689 — MODEL 330 SCREENING AUDIOMETER (October 21, 1991)
  • K895443 — MODEL 210 IMPEDANCE SYSTEM (January 16, 1990)
  • K863984 — MODEL 320 TWO CHANNEL AUDIOMETER (November 18, 1986)
  • K853863 — MODEL 310 IMPEDANCE SYSTEM (December 18, 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