FLOWREST

Humidifier, Respiratory Gas, (direct Patient Interface)

VAPOTHERM, INC.

The following data is part of a premarket notification filed by Vapotherm, Inc. with the FDA for Flowrest.

Pre-market Notification Details

• Device ID: K103316
• 510k Number: K103316
• Device Name: FLOWREST
• Classification: Humidifier, Respiratory Gas, (direct Patient Interface)
• Applicant: VAPOTHERM, INC. 198 Log Canoe Circle Stevensville, MD 21666
• Contact: Gregory A Whitney
• Correspondent: Gregory A Whitney; VAPOTHERM, INC. 198 Log Canoe Circle Stevensville, MD 21666
• Product Code: BTT
• CFR Regulation Number: 868.5450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-11-10
• Decision Date: 2011-02-08
• Summary: summary