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510(k) K930203

MODEL 322 CLINICAL AUDIOMETER by Virtual Corp. — Product Code EWD

K930203 is an FDA 510(k) premarket notification submitted by Virtual Corp. for the device "MODEL 322 CLINICAL AUDIOMETER". The FDA issued a decision of Substantially Equivalent on July 8, 1993. The device falls under product code EWD (Protector, Hearing (Insert)), a Class U device. Virtual Corp. has at least 8 other 510(k) clearances on record.

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 8, 1993
Date Received
January 14, 1993
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Protector, Hearing (Insert)
Device Class
Class U
Regulation Number
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)
  • K926574 — MODEL 330 SCREENING AUDIO METER, MODIFIED (March 29, 1993)
  • K911689 — MODEL 330 SCREENING AUDIOMETER (October 21, 1991)
  • K896301 — MODEL 340 PROBE MIC SYSTEM (January 16, 1990)
  • 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 EWD

  • K020296 — ADULT SILICONE EAR PLUGS, MODELS # 68053, 68057 (June 25, 2002)
  • K972923 — SUPER SILIPLUGS EAR PLUGS (October 27, 1997)
  • K971517 — SILICONE PUTTY EAR PLUGS (June 2, 1997)
  • K962292 — HEARSAVER (October 29, 1996)
  • K960500 — THE VIRTUAL M-332 (April 3, 1996)
  • K945376 — DOC'S PROPLUGS EAR PLUGS (November 14, 1995)
  • K915739 — #903 SILAFLEX II (June 30, 1992)
  • K910177 — SEAL-RITE SILICONE EAR PLUG (June 24, 1991)
  • K862045 — DOC'S PROPLUGS EAR PLUGS (April 10, 1987)
  • K821187 — MEDCO CUSTOM EAR PROTECTOR MOLD KIT (May 27, 1982)

FDA data resources