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 |