BABYSET TM & PAC TM -PULMONARY ASSIST— 510(k) K841264

Substantially Equivalent

Life Design Systems, Inc.

FDA 510(k) clearance K841264 for BABYSET TM & PAC TM -PULMONARY ASSIST, Substantially Equivalent on 1984-06-15. Applicant: Life Design Systems, Inc..

Clearance details

Applicant: Life Design Systems, Inc.
Product code: Code CAI
Advisory panel: Anesthesiology
Date received: 1984-03-26
Decision date: 1984-06-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Mchenry, IL, 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.