MDRIVE— 510(k) K111742

Substantially Equivalent

Embla Systems

FDA 510(k) clearance K111742 for MDRIVE, Substantially Equivalent on 2011-08-31. Applicant: Embla Systems. Device class: 2.

Clearance details

Applicant: Embla Systems
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2011-06-21
Decision date: 2011-08-31
Decision: Substantially Equivalent
Clearance type: Special
Location: Thornton, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code MNR

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