SIRECUST MODEL 960 AND 961 PATIENT MONITORING— 510(k) K872249

Name: FDA 510(k) clearance K872249
Creator: U.S. Food and Drug Administration
Published: 1987-07-21

Substantially Equivalent

Medical Electronics Laboratories, Inc.

FDA 510(k) clearance K872249 for SIRECUST MODEL 960 AND 961 PATIENT MONITORING, Substantially Equivalent on 1987-07-21. Applicant: Medical Electronics Laboratories, Inc.. Device class: 2.

Clearance details

Applicant: Medical Electronics Laboratories, Inc.
Product code: Code DRT
Device class: Class 2
Regulation: 21 CFR 870.2300
Advisory panel: Cardiovascular
Date received: 1987-06-12
Decision date: 1987-07-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Danvers, MA, 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.