SPIROTEL

Spirometer, Diagnostic

MIR MEDICAL INTL. RESEARCH SRL

The following data is part of a premarket notification filed by Mir Medical Intl. Research Srl with the FDA for Spirotel.

Pre-market Notification Details

• Device ID: K043528
• 510k Number: K043528
• Device Name: SPIROTEL
• Classification: Spirometer, Diagnostic
• Applicant: MIR MEDICAL INTL. RESEARCH SRL VIA DEL MAGGIOLINO 125 Roma, IT 00155
• Contact: Simon Fowler
• Correspondent: Simon Fowler; MIR MEDICAL INTL. RESEARCH SRL VIA DEL MAGGIOLINO 125 Roma, IT 00155
• Product Code: BZG
• CFR Regulation Number: 868.1840 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Traditional
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2004-12-21
• Decision Date: 2005-07-19
• Summary: summary