DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300

Thermometer, Electronic, Clinical

RG MEDICAL DIAGNOSTICS

The following data is part of a premarket notification filed by Rg Medical Diagnostics with the FDA for Datatherm Ii Continuous Temperature Monitor, Model Kd-2300.

Pre-market Notification Details

• Device ID: K070878
• 510k Number: K070878
• Device Name: DATATHERM II CONTINUOUS TEMPERATURE MONITOR, MODEL KD-2300
• Classification: Thermometer, Electronic, Clinical
• Applicant: RG MEDICAL DIAGNOSTICS 21130 BRIDGE STREET Southfield, MI 48034
• Contact: Ronald G Le Tourneau
• Correspondent: Ronald G Le Tourneau; RG MEDICAL DIAGNOSTICS 21130 BRIDGE STREET Southfield, MI 48034
• Product Code: FLL
• CFR Regulation Number: 880.2910 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-03-29
• Decision Date: 2007-06-05
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
16148015015013	K070878	000