ACTHERM INFRARED EAR THERMOMETER, ACT 8000 SERIES; PROBE COVER FOR ACTHERM INFRARED EAR THERMOMETER, MODEL MEDACCU2010

Thermometer, Electronic, Clinical

ACTHERM, INC.

The following data is part of a premarket notification filed by Actherm, Inc. with the FDA for Actherm Infrared Ear Thermometer, Act 8000 Series; Probe Cover For Actherm Infrared Ear Thermometer, Model Medaccu2010.

Pre-market Notification Details

• Device ID: K090031
• 510k Number: K090031
• Device Name: ACTHERM INFRARED EAR THERMOMETER, ACT 8000 SERIES; PROBE COVER FOR ACTHERM INFRARED EAR THERMOMETER, MODEL MEDACCU2010
• Classification: Thermometer, Electronic, Clinical
• Applicant: ACTHERM, INC. 6F, NO.18 JHANYE 2ND RD., HSINCHU SCIENCE PARK Hsinchu, TW 30078
• Contact: Richard Hsieh
• Correspondent: Richard Hsieh; ACTHERM, INC. 6F, NO.18 JHANYE 2ND RD., HSINCHU SCIENCE PARK Hsinchu, TW 30078
• Product Code: FLL
• CFR Regulation Number: 880.2910 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2009-01-05
• Decision Date: 2009-04-16
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
06972325560313	K090031	000
06972325560290	K090031	000
06972325560283	K090031	000
06972325560276	K090031	000
06972325560269	K090031	000