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FDA 510(k), K082315, EC50 MICRO+ SMOKERLYZER
FDA 510(k), K082315, EC50 MICRO+ SMOKERLYZER
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510(K) Number: K082315
Device Name: EC50 MICRO+ SMOKERLYZER
Manufacturer: GLEN HILLSLEY
Device Classification Name: Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Regulation Number: CCJ
Classification Product Code: 08/13/2008
Date Received: 02/01/2010
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Toxicology
Device Name: EC50 MICRO+ SMOKERLYZER
Manufacturer: GLEN HILLSLEY
Device Classification Name: Analyzer, Gas, Carbon-Monoxide, Gaseous-Phase
Regulation Number: CCJ
Classification Product Code: 08/13/2008
Date Received: 02/01/2010
Decision Date: Substantially Equivalent (SESE)
Regulation Medical Specialty: Toxicology
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- Status: Pending Fast-Track Request
- Delivery: Approximately 1 to 2 weeks
NOTE: This document is not currently in our library. Upon purchase, we will request the document from the FDA FOIA office. Learn more about Fast-Track Requests here.
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