PATIENT MONITOR CM 135— 510(k) K831164

Substantially Equivalent

Honeywell, Inc.

FDA 510(k) clearance K831164 for PATIENT MONITOR CM 135, Substantially Equivalent on 1983-12-01. Applicant: Honeywell, Inc..

Clearance details

Applicant: Honeywell, Inc.
Product code: Code DRT
Advisory panel: Cardiovascular
Date received: 1983-04-11
Decision date: 1983-12-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Walker, MI, 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.