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

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..

Clearance details

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

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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.