OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47— 510(k) K061426
Substantially EquivalentPorous Media Corp.
FDA 510(k) clearance K061426 for OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47, Substantially Equivalent on 2006-06-05. Applicant: Porous Media Corp.. Device class: 2.
Clearance details
- Applicant
- Porous Media Corp.
- 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
- St. Paul, MN, US
Recent devices under product code CAH
view allMore clearances from Porous Media Corp.
view all- K062091 — POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION
- K990276 — POROUS MEDIA DPB30 SERIES DISPOSABLE PRE-BYPASS FILTER
- K982385 — POROUS MEDIA DPB20 SERIES DISPOSABLE PRE-BYPASS FILTER
- K982127 — POROUS MEDIA DEF25 DISPOSABLE RESPIRATORY FILTER
- K965020 — POROUS MEDIA DBF23 REUSABLE RESPIRATORY FILTER
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.