SPIRODOC

Spirometer, Diagnostic

MEDICAL INTERNATIONAL RESEARCH USA, INC.

The following data is part of a premarket notification filed by Medical International Research Usa, Inc. with the FDA for Spirodoc.

Pre-market Notification Details

• Device ID: K103530
• 510k Number: K103530
• Device Name: SPIRODOC
• Classification: Spirometer, Diagnostic
• Applicant: MEDICAL INTERNATIONAL RESEARCH USA, INC. 1900 PEWAUKEE ROAD SUITE O Waukesha, WI 53188
• Contact: Ed Kohere
• Correspondent: Ed Kohere; MEDICAL INTERNATIONAL RESEARCH USA, INC. 1900 PEWAUKEE ROAD SUITE O Waukesha, WI 53188
• Product Code: BZG
• CFR Regulation Number: 868.1840 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2010-12-01
• Decision Date: 2011-11-21
• Summary: summary

NIH GUDID Devices

Device Identifier	submissionNumber	Supplement
08052990320448	K103530	000
08052990320356	K103530	000