MONITOR, PATIENT, MODEL PM-I0N— 510(k) K770968

Substantially Equivalent

Cavitron Corp.

FDA 510(k) clearance K770968 for MONITOR, PATIENT, MODEL PM-I0N, Substantially Equivalent on 1977-06-08. Applicant: Cavitron Corp..

Clearance details

Applicant: Cavitron Corp.
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 1977-05-31
Decision date: 1977-06-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, US

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Adverse events under product code CCK

product code CCK

Death: 3
Malfunction: 11,428
Total: 11,431

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.