510(k) K873149— NOVAMETRIX END TIDAL CO2 MONITOR, MODEL 1260

Substantially Equivalent

Novametrix Medical Systems, Inc.

Clearance details

Applicant: Novametrix Medical Systems, Inc.
Product code: Code CCK
Advisory panel: Anesthesiology
Date received: 1987-08-11
Decision date: 1987-11-06
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wallingford, CT, US

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.