WAVEGUARD (TM) EEG CAP

Electrode, Cutaneous

EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH

The following data is part of a premarket notification filed by Eemagine Medical Imaging Solutions Gmbh with the FDA for Waveguard (tm) Eeg Cap.

Pre-market Notification Details

• Device ID: K110223
• 510k Number: K110223
• Device Name: WAVEGUARD (TM) EEG CAP
• Classification: Electrode, Cutaneous
• Applicant: EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH 8870 RAVELLO CT Naples, FL 34114
• Contact: Daniel Kamm
• Correspondent: Daniel Kamm; EEMAGINE MEDICAL IMAGING SOLUTIONS GMBH 8870 RAVELLO CT Naples, FL 34114
• Product Code: GXY
• CFR Regulation Number: 882.1320 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-01-25
• Decision Date: 2011-06-29
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
B195CA106	K110223	000
B195CA210	K110223	000
B195CA209	K110223	000
B195CA207	K110223	000
B195CA206	K110223	000
B195CA205	K110223	000
B195CA204	K110223	000
B195CA203	K110223	000
B195CA185	K110223	000
B195XC305	K110223	000
B195CS314	K110223	000
B195CS305	K110223	000
B195CA156	K110223	000
B195CA153	K110223	000
B195CA115	K110223	000
B195CA068	K110223	000
B195CA212	K110223	000
B195CA213	K110223	000
B195CA105	K110223	000
B195CA104	K110223	000
B195CA103	K110223	000
B195CA102	K110223	000
B195XE294	K110223	000
B195XC810	K110223	000
B195CS313	K110223	000
B195CA422	K110223	000
B195CA421	K110223	000
B195CA420	K110223	000
B195CA413	K110223	000
B195CA412	K110223	000
B195CA223	K110223	000
B195CA222	K110223	000
B195CA220	K110223	000
B195CA065	K110223	000
B195XE384	K110223	000
B195CA432	K110223	000
B195CA359	K110223	000
B195CA356	K110223	000
B195CA352	K110223	000
B195CA069	K110223	000
B195XC425	K110223	000
B195XC351	K110223	000
B195CA505	K110223	000
B195CA214	K110223	000
B195CT014	K110223	000
B195CA218	K110223	000
B195XE296	K110223	000
B195XE295	K110223	000
B195XE293	K110223	000
B195XE292	K110223	000
B195CS352	K110223	000
B195CS356	K110223	000
B195XE383	K110223	000
B195XC104	K110223	000
B195XC103	K110223	000
B195CA191	K110223	000
B195CA176	K110223	000
B195CA174	K110223	000
B195CA150	K110223	000
B195CA146	K110223	000
B195CA138	K110223	000
B195CA132	K110223	000
B195CA431	K110223	000
B195XC152	K110223	000
B195XC151	K110223	000
B195XC153	K110223	000
B195CS359	K110223	000
B195CS315	K110223	000
B195XS270	K110223	000
B195XC301	K110223	000
B195XC240REF0	K110223	000
B195XC240GND0	K110223	000
B195XC240EOG0	K110223	000
B195XC240BBB0	K110223	000
B195XC240	K110223	000
B195XC163	K110223	000
B195XC161	K110223	000
B195XC141	K110223	000
B195XC135	K110223	000
B195XC133	K110223	000
B195XC127	K110223	000
B195XC118	K110223	000
B195XC113	K110223	000
B195XC110	K110223	000
B195XC302	K110223	000
B195XE125	K110223	000
B195XE391	K110223	000
B195XE385C0	K110223	000
B195XE385	K110223	000
B195XE277	K110223	000
B195XE126	K110223	000
B195XE1255C0	K110223	000
B195XE1255A0	K110223	000
B195XE1254C0	K110223	000
B195XE1254A0	K110223	000
B195XE1253C0	K110223	000
B195XE1253A0	K110223	000
B195XE1252C0	K110223	000
B195XE1252A0	K110223	000
B195XE1251C0	K110223	000
B195XE1251A0	K110223	000
B195XC109	K110223	000
B195XC108	K110223	000
B195CA326	K110223	000
B195CA319	K110223	000
B195CA318	K110223	000
B195CA316	K110223	000
B195CA315	K110223	000
B195CA221	K110223	000
B195CA208	K110223	000
B195CA202	K110223	000
B195CA201	K110223	000
B195CA200	K110223	000
B195CA195	K110223	000
B195CA162	K110223	000
B195CA134	K110223	000
B195CA126	K110223	000
B195CA118	K110223	000
B195CA401	K110223	000
B195CA411	K110223	000
B195XC005	K110223	000
B195XC004	K110223	000
B195XC003	K110223	000
B195XC002	K110223	000
B195XC001	K110223	000
B195RC325	K110223	000
B195RC324	K110223	000
B195RC318	K110223	000
B195RC317	K110223	000
B195RC316	K110223	000
B195RC315	K110223	000
B195CS312	K110223	000
B195CS311	K110223	000
B195CS301	K110223	000
B195CA430	K110223	000
B195CA116	K110223	000