PNEUPAC VR1 AIR MIX— 510(k) K071527

Substantially Equivalent

Smiths Medical International , Ltd.

FDA 510(k) clearance K071527 for PNEUPAC VR1 AIR MIX, Substantially Equivalent on 2007-10-04. Applicant: Smiths Medical International , Ltd..

Clearance details

Applicant: Smiths Medical International , Ltd.
Product code: Code BTL
Advisory panel: Anesthesiology
Date received: 2007-06-04
Decision date: 2007-10-04
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Waukesha, WI, US

Download summary PDF View on FDA.gov ↗

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.