Temp Pal

Thermometer, Electronic, Clinical

IWEECARE Co., Ltd.

The following data is part of a premarket notification filed by Iweecare Co., Ltd. with the FDA for Temp Pal.

Pre-market Notification Details

• Device ID: K202603
• 510k Number: K202603
• Device Name: Temp Pal
• Classification: Thermometer, Electronic, Clinical
• Applicant: iWEECARE Co., Ltd. 2F, No. 121, Sec. 2, Linong St., Beitou Dist., Taipei City, TW 112
• Contact: Glen Tseng
• Correspondent: Shao-chun Chen; iWEECARE Co., Ltd. 2625 Middlefield Road, #113 Palo Alto, CA 94306
• Product Code: FLL
• CFR Regulation Number: 880.2910 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2020-09-08
• Decision Date: 2021-07-22