LIFEWATCH(R) PORTABLE MONITORING SYSTEM— 510(k) K864419

Name: FDA 510(k) clearance K864419
Creator: U.S. Food and Drug Administration
Published: 1987-03-16

Substantially Equivalent

Lifewatch Systems, Inc.

FDA 510(k) clearance K864419 for LIFEWATCH(R) PORTABLE MONITORING SYSTEM, Substantially Equivalent on 1987-03-16. Applicant: Lifewatch Systems, Inc.. Device class: 2.

Clearance details

Applicant: Lifewatch Systems, Inc.
Product code: Code BZQ
Device class: Class 2
Regulation: 21 CFR 868.2375
Advisory panel: Anesthesiology
Date received: 1986-11-10
Decision date: 1987-03-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Attleboro, MA, US

Download summary PDF View on FDA.gov ↗

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