QUIK-CAP

Electrode, Cutaneous

NEUROSCAN

The following data is part of a premarket notification filed by Neuroscan with the FDA for Quik-cap.

Pre-market Notification Details

• Device ID: K000865
• 510k Number: K000865
• Device Name: QUIK-CAP
• Classification: Electrode, Cutaneous
• Applicant: NEUROSCAN 45150 BUSINESS CT., SUITE 100 Sterling, VA 20166
• Contact: David B Jones
• Correspondent: David B Jones; NEUROSCAN 45150 BUSINESS CT., SUITE 100 Sterling, VA 20166
• Product Code: GXY
• CFR Regulation Number: 882.1320 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2000-03-17
• Decision Date: 2000-04-18

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
09342451004772	K000865	000
09342451004659	K000865	000
09342451004673	K000865	000
09342451004680	K000865	000
09342451004697	K000865	000
09342451004703	K000865	000
09342451004710	K000865	000
09342451004727	K000865	000
09342451004734	K000865	000
09342451004741	K000865	000
09342451004642	K000865	000
09342451004635	K000865	000
09342451004628	K000865	000
09342451003904	K000865	000
09342451003980	K000865	000
09342451003997	K000865	000
09342451004000	K000865	000
09342451004017	K000865	000
09342451004024	K000865	000
09342451004031	K000865	000
09342451004314	K000865	000
09342451004611	K000865	000
09342451004758	K000865	000
09342451004765	K000865	000
09342451004789	K000865	000
09342451006097	K000865	000
09342451006219	K000865	000
09342451006226	K000865	000
09342451006233	K000865	000
09342451006240	K000865	000
09342451006257	K000865	000
09342451006264	K000865	000
09342451006271	K000865	000
09342451006288	K000865	000
09342451006080	K000865	000
09342451006073	K000865	000
09342451006066	K000865	000
09342451004796	K000865	000
09342451004802	K000865	000
09342451004819	K000865	000
09342451004826	K000865	000
09342451004833	K000865	000
09342451006028	K000865	000
09342451006035	K000865	000
09342451006042	K000865	000
09342451006059	K000865	000
09342451006349	K000865	000