SURETEMP PLUS

Thermometer, Electronic, Clinical

WELCH ALLYN, INC.

The following data is part of a premarket notification filed by Welch Allyn, Inc. with the FDA for Suretemp Plus.

Pre-market Notification Details

• Device ID: K030580
• 510k Number: K030580
• Device Name: SURETEMP PLUS
• Classification: Thermometer, Electronic, Clinical
• Applicant: WELCH ALLYN, INC. 7420 CARROLL RD. San Diego, CA 92121 -2334
• Contact: Debra L Jackson
• Correspondent: Debra L Jackson; WELCH ALLYN, INC. 7420 CARROLL RD. San Diego, CA 92121 -2334
• Product Code: FLL
• CFR Regulation Number: 880.2910 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2003-02-24
• Decision Date: 2003-05-06
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
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