510(k) K950116
K950116 is an FDA 510(k) premarket notification submitted by Kaz, Inc. for the device "THERASTEAM PERSONAL STEAM INHALER". The FDA issued a decision of Substantially Equivalent on February 10, 1995. The device falls under product code KFZ (Humidifier, Non-Direct Patient Interface (Home-Use)), a Class I device regulated under 21 CFR 868.5460. Kaz, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 10, 1995
- Date Received
- January 11, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Humidifier, Non-Direct Patient Interface (Home-Use)
- Device Class
- Class I
- Regulation Number
- 868.5460
- Review Panel
- AN
- Submission Type