The following data is part of a premarket notification filed by Kaz, Inc. with the FDA for Therasteam Personal Steam Inhaler.
Device ID | K950116 |
510k Number | K950116 |
Device Name: | THERASTEAM PERSONAL STEAM INHALER |
Classification | Humidifier, Non-direct Patient Interface (home-use) |
Applicant | KAZ, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, NW Washington, DC 20004 -1109 |
Contact | Jonathan S Kahan |
Correspondent | Jonathan S Kahan KAZ, INC. COLUMBIA SQUARE 555 THIRTEENTH STREET, NW Washington, DC 20004 -1109 |
Product Code | KFZ |
CFR Regulation Number | 868.5460 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-01-11 |
Decision Date | 1995-02-10 |