PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX (K020550) — FDA 510(k) Clearance | Predicase

K-number	K020550
Device name	PASSPORT 2 WITH VIEW 12 ECG ANALYSIS MODULE MODEL # 0998-00-0170-XXXX
Applicant	Datascope Corp.
Product code	DSI
Device class	Class II
Decision date	Aug 28, 2002
Decision	Substantially Equivalent
Regulation	870.1025

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View the full FDA submission: accessdata.fda.gov

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