DFI-1000 AND DVS-475 IMAGING DEVICES

System, X-ray, Fluoroscopic, Image-intensified

NICAL

The following data is part of a premarket notification filed by Nical with the FDA for Dfi-1000 And Dvs-475 Imaging Devices.

Pre-market Notification Details

• Device ID: K951261
• 510k Number: K951261
• Device Name: DFI-1000 AND DVS-475 IMAGING DEVICES
• Classification: System, X-ray, Fluoroscopic, Image-intensified
• Applicant: NICAL 3 HUDSON TERRACE Dobbs Ferry, NY 10522
• Contact: Gerald Silverman
• Correspondent: Gerald Silverman; NICAL 3 HUDSON TERRACE Dobbs Ferry, NY 10522
• Product Code: JAA
• CFR Regulation Number: 892.1650 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1995-03-21
• Decision Date: 1996-03-15

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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