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510(k) K141582

CP150 ELECTROCARDIOGRAPH WITH SPIROMETRY OPTION by Welch Allyn — Product Code DPS

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
July 11, 2014
Date Received
June 13, 2014
Clearance Type
Special
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Electrocardiograph
Device Class
Class II
Regulation Number
870.2340
Review Panel
CV
Submission Type

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  • K142356 — Connex Spot Monitor,901058 Vital Signs Monitor Core (December 19, 2014)
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  • K132808 — VITAL SIGNS MONITOR, CONNEX VITAL SIGNS MONITOR (November 20, 2013)

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