PRECISION FLOW

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 Precision Flow.

Pre-market Notification Details

• Device ID: K072845
• 510k Number: K072845
• Device Name: PRECISION FLOW
• Classification: Humidifier, Respiratory Gas, (direct Patient Interface)
• Applicant: VAPOTHERM, INC. 555 THIRTEENTH STREET, NW Washington, DC 21666
• Contact: Jonathan S Kahn
• Correspondent: Jonathan S Kahn; VAPOTHERM, INC. 555 THIRTEENTH STREET, NW Washington, DC 21666
• Product Code: BTT
• CFR Regulation Number: 868.5450 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2007-10-04
• Decision Date: 2008-07-17
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
00841737105213	K072845	000
00841737105060	K072845	000
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