MDRIVE

Ventilatory Effort Recorder

EMBLA SYSTEMS

The following data is part of a premarket notification filed by Embla Systems with the FDA for Mdrive.

Pre-market Notification Details

• Device ID: K111742
• 510k Number: K111742
• Device Name: MDRIVE
• Classification: Ventilatory Effort Recorder
• Applicant: EMBLA SYSTEMS 9351 GRANT STREET SUITE 600 Thornton, CO 80229
• Contact: Robert G Schueppert
• Correspondent: Robert G Schueppert; EMBLA SYSTEMS 9351 GRANT STREET SUITE 600 Thornton, CO 80229
• Product Code: MNR
• CFR Regulation Number: 868.2375 [🔎]
• Decision: Substantially Equivalent (SESE)
• Type: Special
• 3rd Party Reviewed: No
• Combination Product: No
• Date Received: 2011-06-21
• Decision Date: 2011-08-31
• Summary: summary