IOB Temperature Management System

System, Thermal Regulating

IOB MEDICAL INC

The following data is part of a premarket notification filed by Iob Medical Inc with the FDA for Iob Temperature Management System.

Pre-market Notification Details

• Device ID: K162679
• 510k Number: K162679
• Device Name: IOB Temperature Management System
• Classification: System, Thermal Regulating
• Applicant: IOB MEDICAL INC 504E DIAMOND AVE., SUITE I Gaithersburg, MD 20877
• Contact: Jiulin Xia
• Correspondent: Joe Shia; LSI INTERNATIONAL INC 504E DIAMOND AVE., SUITE F Gaithersburg, MD 20877
• Product Code: DWJ
• CFR Regulation Number: 870.5900 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2016-09-26
• Decision Date: 2017-04-28
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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