RM-301 PATIENT MONITOR— 510(k) K880498

Name: FDA 510(k) clearance K880498
Creator: U.S. Food and Drug Administration
Published: 1988-05-13

Substantially Equivalent

Ppg Industries, Inc.

FDA 510(k) clearance K880498 for RM-301 PATIENT MONITOR, Substantially Equivalent on 1988-05-13. Applicant: Ppg Industries, Inc.. Device class: 2.

Clearance details

Applicant: Ppg Industries, Inc.
Product code: Code DRT
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 1988-02-05
Decision date: 1988-05-13
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pleasantville, NY, US

Download summary PDF View on FDA.gov ↗

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Adverse events under product code DRT

product code DRT

Death: 4
Total: 4

Source: openFDA MAUDE database, 2020-01-01 through 2026-04-23. Counts aggregate all devices under this product code, not just this specific clearance. Reports are submissions to FDA, not validated events. Search MAUDE directly →

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