CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECOR— 510(k) K863100

Substantially Equivalent

Honeywell, Inc.

FDA 510(k) clearance K863100 for CEN STA MON AC/DC ALARM CENTRAL ACCES ALARM RECOR, Substantially Equivalent on 1987-02-03. Applicant: Honeywell, Inc..

Clearance details

Applicant
Honeywell, Inc.
Product code
Code DPS
Advisory panel
Cardiovascular
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Pleasantville, NY, US
Download summary PDFView on FDA.gov ↗

Adverse events under product code DPS

product code DPS
Death
7
Total
7

Source: openFDA MAUDE database, through . 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.