XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS.— 510(k) K901514

Name: FDA 510(k) clearance K901514
Creator: U.S. Food and Drug Administration
Published: 1990-11-16

Substantially Equivalent

Ppg Industries, Inc.

FDA 510(k) clearance K901514 for XR MODEL H PHYSIOLOGICAL MONITOR & RECORDING SYS., Substantially Equivalent on 1990-11-16. Applicant: Ppg Industries, Inc.. Device class: 2.

Clearance details

Applicant: Ppg Industries, Inc.
Product code: Code DSK
Device class: Class 2
Regulation: 21 CFR 870.1110
Advisory panel: Cardiovascular
Date received: 1990-03-30
Decision date: 1990-11-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Lenexa, KS, US

Download summary PDF View on FDA.gov ↗

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