HI-LO TEMP TYMPANIC TEMP. SENSOR

Thermometer, Electronic, Clinical

MALLINCKRODT CRITICAL CARE

The following data is part of a premarket notification filed by Mallinckrodt Critical Care with the FDA for Hi-lo Temp Tympanic Temp. Sensor.

Pre-market Notification Details

• Device ID: K832635
• 510k Number: K832635
• Device Name: HI-LO TEMP TYMPANIC TEMP. SENSOR
• Classification: Thermometer, Electronic, Clinical
• Applicant: MALLINCKRODT CRITICAL CARE 803 N. Front St. Suite 3 Mchenry, IL 60050
• Product Code: FLL
• CFR Regulation Number: 880.2910 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 1983-08-04
• Decision Date: 1983-10-04

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
10884521031586	K832635	000