Servo Guard

Filter, Bacterial, Breathing-circuit

Maquet Critical Care AB

The following data is part of a premarket notification filed by Maquet Critical Care Ab with the FDA for Servo Guard.

Pre-market Notification Details

• Device ID: K182862
• 510k Number: K182862
• Device Name: Servo Guard
• Classification: Filter, Bacterial, Breathing-circuit
• Applicant: Maquet Critical Care AB Rontgenvagen 2 Solna, SE Se-171 54
• Contact: Elise Brun
• Correspondent: Mark Dinger; Maquet Medical Systems USA 45 Barbour Pond Drive Wayne, NJ 07470
• Product Code: CAH
• CFR Regulation Number: 868.5260 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2018-10-11
• Decision Date: 2019-10-21
• Summary: summary