CORON PRES MONITOR KIT MODEL 80 LEFT KIT MODEL 90— 510(k) K853072

Substantially Equivalent

Camino Laboratories, Inc.

FDA 510(k) clearance K853072 for CORON PRES MONITOR KIT MODEL 80 LEFT KIT MODEL 90, Substantially Equivalent on 1985-12-09. Applicant: Camino Laboratories, Inc..

Clearance details

Applicant: Camino Laboratories, Inc.
Product code: Code DYB
Advisory panel: Cardiovascular
Date received: 1985-07-23
Decision date: 1985-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: San Diego, CA, US

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Adverse events under product code DYB

product code DYB

Death: 808
Injury: 5,922
Malfunction: 16,516
Other: 5
Total: 23,251

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.