CRITIKON 48-HOUR AIR ELIMINATING FILTER— 510(k) K861644

Clearance details

Applicant

Critikon Company, LLC

Product code

Code FPB

Device class

Class 2

Regulation

21 CFR 880.5440

Advisory panel

General Hospital

Date received

1986-04-30

Decision date

1986-07-22

Decision

Substantially Equivalent

Clearance type

Traditional

Location

Tampa, FL, US

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Other

1

Total

1

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 →