INFRASCANNER

Infrared Hematoma Detector

INFRASCAN, INC.

The following data is part of a premarket notification filed by Infrascan, Inc. with the FDA for Infrascanner.

Pre-market Notification Details

• Device ID: K120949
• 510k Number: K120949
• Device Name: INFRASCANNER
• Classification: Infrared Hematoma Detector
• Applicant: INFRASCAN, INC. 1835 MARKET ST., 29TH FLOOR Philadelphia, PA 19103
• Contact: Steven B Datlof, M.d., J.d.
• Correspondent: Steven B Datlof, M.d., J.d.; INFRASCAN, INC. 1835 MARKET ST., 29TH FLOOR Philadelphia, PA 19103
• Product Code: OPT
• CFR Regulation Number: 882.1935 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2012-03-30
• Decision Date: 2013-01-11
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00861606000302	K120949	000