PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403— 510(k) K862647

Name: FDA 510(k) clearance K862647
Creator: U.S. Food and Drug Administration
Published: 1986-08-18

Substantially Equivalent

Ivy Biomedical Systems, Inc.

FDA 510(k) clearance K862647 for PHYSIOLOGICAL MONITOR, MODELS 401,402 & 403, Substantially Equivalent on 1986-08-18. Applicant: Ivy Biomedical Systems, Inc.. Device class: 2.

Clearance details

Applicant: Ivy Biomedical Systems, Inc.
Product code: Code DSK
Device class: Class 2
Regulation: 21 CFR 870.1110
Advisory panel: Cardiovascular
Date received: 1986-07-11
Decision date: 1986-08-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Branford, CT, US

Download summary PDF View on FDA.gov ↗

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