COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER SUPPLY (MAINS)— 510(k) K040090

Substantially Equivalent

Pneupac , Ltd.

FDA 510(k) clearance K040090 for COMPPAC 200HD; CS12 POWER SUPPLY (AIRCRAFT/VECHILE); PS11 POWER SUPPLY (MAINS), Substantially Equivalent on 2004-05-27. Applicant: Pneupac , Ltd..

Clearance details

Applicant: Pneupac , Ltd.
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 2004-01-16
Decision date: 2004-05-27
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

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Adverse events under product code BTL

product code BTL

Death: 8
Malfunction: 3,256
Other: 1
Total: 3,265

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.