MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT— 510(k) K904538

Substantially Equivalent

Mauna Loa Medical, Inc.

FDA 510(k) clearance K904538 for MAUNA LOA ENHANCED HEATED BREATHING CIRCUIT, Substantially Equivalent on 1991-04-24. Applicant: Mauna Loa Medical, Inc..

Clearance details

Applicant: Mauna Loa Medical, Inc.
Product code: Code CAI
Advisory panel: Anesthesiology
Date received: 1990-10-04
Decision date: 1991-04-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Las Vegas, NV, US

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Adverse events under product code CAI

product code CAI

Malfunction: 869
Other: 1
Total: 870

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.