SPHERZ

Neurological Stereotaxic Instrument

I.Z.I. CORP.

The following data is part of a premarket notification filed by I.z.i. Corp. with the FDA for Spherz.

Pre-market Notification Details

• Device ID: K022074
• 510k Number: K022074
• Device Name: SPHERZ
• Classification: Neurological Stereotaxic Instrument
• Applicant: I.Z.I. CORP. 7020 TUDSBURY RD. Baltimore, MD 21244
• Contact: Helen Zinreich
• Correspondent: Helen Zinreich; I.Z.I. CORP. 7020 TUDSBURY RD. Baltimore, MD 21244
• Product Code: HAW
• CFR Regulation Number: 882.4560 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2002-06-26
• Decision Date: 2002-08-13

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00815212020575	K022074	000
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