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510(k) K062468

SPECTRUM M2 MONITOR by Spectrum Medical, Llp — Product Code DRY

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
September 13, 2006
Date Received
August 24, 2006
Clearance Type
Traditional
Expedited Review
No
Third Party Review
Yes

Device Classification

Device Name
Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass
Device Class
Class II
Regulation Number
870.4330
Review Panel
CV
Submission Type

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