INTEGRITY, MODEL V500

Stimulator, Auditory, Evoked Response

VIVOSONIC, INC.

The following data is part of a premarket notification filed by Vivosonic, Inc. with the FDA for Integrity, Model V500.

Pre-market Notification Details

• Device ID: K043396
• 510k Number: K043396
• Device Name: INTEGRITY, MODEL V500
• Classification: Stimulator, Auditory, Evoked Response
• Applicant: VIVOSONIC, INC. 56 ABERFOYLE CRESCENT SUITE 620 Toronto, On, CA M8x 2w4
• Contact: Edward Goss
• Correspondent: N.e. Devine; ENTELA, INC. 3033 MADISON AVENUE, SE Grand Rapids, MI 49548
• Product Code: GWJ
• CFR Regulation Number: 882.1900 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: Yes
• Combination Product: No
• Date Received: 2004-12-10
• Decision Date: 2005-01-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00627908020192	K043396	000
00627908020031	K043396	000
00627908020048	K043396	000
00627908020055	K043396	000
00627908020062	K043396	000
00627908020079	K043396	000
00627908020086	K043396	000
00627908020093	K043396	000
00627908020109	K043396	000
00627908020116	K043396	000
00627908020123	K043396	000
00627908020130	K043396	000
00627908020024	K043396	000
00627908020017	K043396	000
00627908020178	K043396	000
00627908020185	K043396	000
00627908020154	K043396	000
00062790820145	K043396	000
00627908010018	K043396	000
00627908010025	K043396	000
00627908010032	K043396	000
00627908010049	K043396	000
00627908010056	K043396	000
00627908010063	K043396	000
00627908010070	K043396	000
00627908020147	K043396	000
00627908070067	K043396	000
00062790820039	K043396	000
00062790820046	K043396	000
00062790820053	K043396	000
00062790820060	K043396	000
00062790820077	K043396	000
00062790820084	K043396	000
00062790820091	K043396	000
00062790820107	K043396	000
00062790820114	K043396	000
00062790820121	K043396	000
00062790820138	K043396	000
00062790820022	K043396	000
00062790820015	K043396	000
00627908070074	K043396	000
00627908090010	K043396	000
00062790870065	K043396	000
00062790870072	K043396	000
00062790810016	K043396	000
00062790810023	K043396	000
00062790810030	K043396	000
00062790810047	K043396	000
00062790810054	K043396	000
00062790810061	K043396	000
00062790810078	K043396	000
00062790890018	K043396	000