S-Line

Warmer, Thermal, Infusion Fluid

Barkey GmbH & Co. KG

The following data is part of a premarket notification filed by Barkey Gmbh & Co. Kg with the FDA for S-line.

Pre-market Notification Details

• Device ID: K213191
• 510k Number: K213191
• Device Name: S-Line
• Classification: Warmer, Thermal, Infusion Fluid
• Applicant: Barkey GmbH & Co. KG Gewerbestr. 8 Leopoldshoehe, DE 33818
• Contact: Thomas Barkey
• Correspondent: Paul Dryden; ProMedic Consulting LLC 131 Bay Point Dr NE Saint Petersburg, FL 33704
• Product Code: LGZ
• CFR Regulation Number: 880.5725 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2021-09-29
• Decision Date: 2022-05-24

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04059201002203	K213191	000