STERILE DISPOSABLES FOR MER

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 Sterile Disposables For Mer.

Pre-market Notification Details

• Device ID: K120098
• 510k Number: K120098
• Device Name: STERILE DISPOSABLES FOR MER
• Classification: Electrode, Depth
• Applicant: ALPHA OMEGA ENGINEERING, LTD. 1 HA'RAKEFET ST., P.O BOX 4262 Zichron Yaacov, IL 30900
• Contact: Ilan Sharon
• Correspondent: Ilan Sharon; ALPHA OMEGA ENGINEERING, LTD. 1 HA'RAKEFET ST., P.O BOX 4262 Zichron Yaacov, IL 30900
• Product Code: GZL
• CFR Regulation Number: 882.1330 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-01-12
• Decision Date: 2012-06-12

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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