NEUROPROBES

Electrode, Depth

ALPHA OMEGA ENGINEERING, LTD.

The following data is part of a premarket notification filed by Alpha Omega Engineering, Ltd. with the FDA for Neuroprobes.

Pre-market Notification Details

• Device ID: K052527
• 510k Number: K052527
• Device Name: NEUROPROBES
• Classification: Electrode, Depth
• Applicant: ALPHA OMEGA ENGINEERING, LTD. HA'AVODA ST., P.O. BOX 810 Nazareth Illit, IL 17105
• Contact: Shlomo Pundak
• Correspondent: Shlomo Pundak; ALPHA OMEGA ENGINEERING, LTD. HA'AVODA ST., P.O. BOX 810 Nazareth Illit, IL 17105
• Product Code: GZL
• CFR Regulation Number: 882.1330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2005-09-12
• Decision Date: 2006-04-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
07290016450620	K052527	000
07290016450439	K052527	000
07290016450422	K052527	000
07290016450415	K052527	000
07290016450408	K052527	000
07290016450392	K052527	000
07290016450385	K052527	000
07290016450378	K052527	000
07290016450361	K052527	000
07290016450354	K052527	000
07290016450347	K052527	000
07290016450330	K052527	000
07290016450323	K052527	000
07290016450316	K052527	000
17290014954882	K052527	000
17290014954851	K052527	000
17290014954363	K052527	000
07290016450446	K052527	000
07290016450453	K052527	000
07290016450613	K052527	000
07290016450606	K052527	000
07290016450590	K052527	000
07290016450583	K052527	000
07290016450576	K052527	000
07290016450569	K052527	000
07290016450552	K052527	000
07290016450545	K052527	000
07290016450538	K052527	000
07290016450521	K052527	000
07290016450514	K052527	000
07290016450507	K052527	000
07290016450491	K052527	000
07290016450484	K052527	000
07290016450477	K052527	000
07290016450460	K052527	000
17290014954035	K052527	000