FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT

Calculator, Predicted Values, Pulmonary Function

VIASYS HEALTHCARE GMBH

The following data is part of a premarket notification filed by Viasys Healthcare Gmbh with the FDA for Flowscreen, Flowscreen/corscreen, Flowscreen Ct.

Pre-market Notification Details

• Device ID: K080734
• 510k Number: K080734
• Device Name: FLOWSCREEN, FLOWSCREEN/CORSCREEN, FLOWSCREEN CT
• Classification: Calculator, Predicted Values, Pulmonary Function
• Applicant: VIASYS HEALTHCARE GMBH LEIBNIZSTRASSE 7 Hoechberg, DE 97204
• Contact: Thomas Rust
• Correspondent: Thomas Rust; VIASYS HEALTHCARE GMBH LEIBNIZSTRASSE 7 Hoechberg, DE 97204
• Product Code: BTY
• CFR Regulation Number: 868.1890 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2008-03-14
• Decision Date: 2008-06-26
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
04057155000368	K080734	000
04057155000139	K080734	000
04057155000122	K080734	000
04057155000078	K080734	000