POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION
FDA 510(k) clearance K062091 · decided 2006-08-08
Clearance details
- K-number
- K062091
- Device name
- POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION
- Applicant
- Porous Media Corp.
- Decision
- Substantially Equivalent
- Date received
- 2006-07-24
- Decision date
- 2006-08-08
- Days to decision
- 15 days
- Clearance type
- Traditional
- Product code
- BTT
- Device class
- 2
- Regulation number
- 868.5450
- Medical specialty
- Anesthesiology
- Advisory committee
- Anesthesiology
- Location
- St. Paul, MN, US
- Third-party review
- Yes
- Expedited review
- No
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Recalls involving this device
| Record | Firm | Date |
|---|---|---|
| HUMIDIFLOW Respiratory Gas Humidifier; Manufactured by: Porous Media Corporation 1350 Hamm recall (Z-0935-2007) | Porous Media Corporation | 2007-06-20 |