Home / 510(k) Clearances / K960500

510(k) K960500

THE VIRTUAL M-332 by Virtual Corp. — Product Code EWD

K960500 is an FDA 510(k) premarket notification submitted by Virtual Corp. for the device "THE VIRTUAL M-332". The FDA issued a decision of Substantially Equivalent on April 3, 1996. 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
April 3, 1996
Date Received
February 2, 1996
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.

  • 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)
  • 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)
  • K945376 — DOC'S PROPLUGS EAR PLUGS (November 14, 1995)
  • K930203 — MODEL 322 CLINICAL AUDIOMETER (July 8, 1993)
  • 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