Tempo Smart Button

Injection Data Capture Device

Eli Lilly And Company

The following data is part of a premarket notification filed by Eli Lilly And Company with the FDA for Tempo Smart Button.

Pre-market Notification Details

• Device ID: K212217
• 510k Number: K212217
• Device Name: Tempo Smart Button
• Classification: Injection Data Capture Device
• Applicant: Eli Lilly And Company Lilly Corporate Center Indianapolis, IL 46285
• Contact: Kevin S. Bardonner
• Correspondent: Marcia Arentz; Eli Lilly And Company Lilly Corporate Center Indianapolis, IN 46285
• Product Code: QOG
• CFR Regulation Number: 880.5860 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-07-16
• Decision Date: 2022-09-16

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
30300020947554	K212217	000
50300021151558	K212217	000