The following data is part of a premarket notification filed by Porous Media Corp. with the FDA for Porous Media Humidiflow Humidifier For Universal Humidification.
| Device ID | K062091 |
| 510k Number | K062091 |
| Device Name: | POROUS MEDIA HUMIDIFLOW HUMIDIFIER FOR UNIVERSAL HUMIDIFICATION |
| Classification | Humidifier, Respiratory Gas, (direct Patient Interface) |
| Applicant | POROUS MEDIA CORP. 1350 HAMMOND RD. St. Paul, MN 55110 |
| Contact | Keith A Roberts |
| Correspondent | Neil E Devine INTERTEK TESTING SERVICES 2307 EAST AURORA ROAD UNIT B7 Twinsburg, OH 44087 |
| Product Code | BTT |
| CFR Regulation Number | 868.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | Yes |
| Combination Product | No |
| Date Received | 2006-07-24 |
| Decision Date | 2006-08-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| B462IP3 | K062091 | 000 |