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 |