PROTEKTOR 32

Stimulator, Electrical, Evoked Response

NATUS MEDICAL, INC.

The following data is part of a premarket notification filed by Natus Medical, Inc. with the FDA for Protektor 32.

Pre-market Notification Details

• Device ID: K093304
• 510k Number: K093304
• Device Name: PROTEKTOR 32
• Classification: Stimulator, Electrical, Evoked Response
• Applicant: NATUS MEDICAL, INC. 2568 BRISTOL CIRCLE Oakville, Ontario, CA L6h 5s1
• Contact: Goldy Singh
• Correspondent: Goldy Singh; NATUS MEDICAL, INC. 2568 BRISTOL CIRCLE Oakville, Ontario, CA L6h 5s1
• Product Code: GWF
• Subsequent Product Code: GWE
• Subsequent Product Code: GWJ
• Subsequent Product Code: OLT
• CFR Regulation Number: 882.1870 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-10-21
• Decision Date: 2010-08-11

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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