PALL ULTIPOR ANESTHESIA BREATHING SYSTEM— 510(k) K013093

Substantially Equivalent

Pall Medical

FDA 510(k) clearance K013093 for PALL ULTIPOR ANESTHESIA BREATHING SYSTEM, Substantially Equivalent on 2002-08-01. Applicant: Pall Medical. Device class: 2.

Clearance details

Applicant
Pall Medical
Product code
Code CAH
Device class
Class 2
Regulation
21 CFR 868.5260
Advisory panel
Anesthesiology
Date received
Decision date
Decision
Substantially Equivalent
Clearance type
Traditional
Location
Ann Arbor, MI, US
Download summary PDFView on FDA.gov ↗

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Adverse events under product code CAH

product code CAH
Death
7
Total
7

Source: openFDA MAUDE database, through . 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.