RMX PHYSIOLOGICAL DATA RECORDER— 510(k) K080375

Substantially Equivalent

S.L.P. , Ltd.

FDA 510(k) clearance K080375 for RMX PHYSIOLOGICAL DATA RECORDER, Substantially Equivalent on 2008-09-02. Applicant: S.L.P. , Ltd.. Device class: 2.

Clearance details

Applicant: S.L.P. , Ltd.
Product code: Code MNR
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 2008-02-12
Decision date: 2008-09-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Tel-Aviv, IL

Download summary PDF View on FDA.gov ↗

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