POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION— 510(k) K062091
Substantially EquivalentPorous Media Corp.
FDA 510(k) clearance K062091 for POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION, Substantially Equivalent on 2006-08-08. Applicant: Porous Media Corp.. Device class: 2.
Clearance details
- Applicant
- Porous Media Corp.
- Product code
- Code BTT
- Device class
- Class 2
- Regulation
- 21 CFR 868.5450
- Advisory panel
- Anesthesiology
- Date received
- Decision date
- Decision
- Substantially Equivalent
- Clearance type
- Traditional
- Location
- St. Paul, MN, US
Recent devices under product code BTT
view allMore clearances from Porous Media Corp.
view all- K061426 — OXYGEN CONCENTRATOR FILTERS, MODELS DBF32, DBF24, DBF27, DBF25, DFC06 AND DDF47
- 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 BTT
product code BTT- Death
- 60
- Injury
- 152
- Malfunction
- 7,232
- Other
- 2
- Total
- 7,446
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.