MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180— 510(k) K101982

Name: FDA 510(k) clearance K101982
Creator: U.S. Food and Drug Administration
Published: 2010-12-21

Substantially Equivalent

St Jude Medical, Crmd

FDA 510(k) clearance K101982 for MERLIN PSA PATIENT CABLE EX 3150, CABLE ADAPTER EX3170, M ADAPTER EX3180, Substantially Equivalent on 2010-12-21. Applicant: St Jude Medical, Crmd. Device class: 2.

Clearance details

Applicant: St Jude Medical, Crmd
Product code: Code DTA
Device class: Class 2
Regulation: 21 CFR 870.3720
Advisory panel: Cardiovascular
Date received: 2010-07-14
Decision date: 2010-12-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sunnyvale, CA, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.