UNIPOR BREATHING CIRCUIT FILTER— 510(k) K791307

Substantially Equivalent

Pall Biomedical Products Co.

FDA 510(k) clearance K791307 for UNIPOR BREATHING CIRCUIT FILTER, Substantially Equivalent on 1979-08-03. Applicant: Pall Biomedical Products Co.. Device class: 2.

Clearance details

Applicant
Pall Biomedical Products Co.
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
Walker, 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 →

Recalls naming K791307

K-number listed on FDA's recall record

Matched by K-number from FDA's Recall Enterprise System record (openFDA device/recallk_numbers) — these recalls explicitly list K791307.

Data sourced from openFDA. This site is unofficial and independent of the FDA.