FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
ULTRASONIC COOL SPRAY HUMIDIFIER
K Number: K842275
·
Decision Aug 14, 1984
Classifications
1
FEI Numbers
119
Registration Numbers
119
Same Product Code
19
Applicant Total
3
Review Days
67
Research this 510(k) in seconds
The Research Assistant summarizes clearance history, predicates and product-code trends — and cites every record.
Free to try · every answer cites its records
Basic Information
- Device Name
- ULTRASONIC COOL SPRAY HUMIDIFIER
- K Number
- K842275
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5460
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Sunbeam Corp.
- Date Received
- June 8, 1984
- Decision Date
- August 14, 1984
- Product Code
- KFZ
- Advisory Committee
- Anesthesiology
- Review Advisory Committee
- AN
- Third Party
- N
Classifications
This FDA 510(k) entry is associated with 1 FDA classification via its product code.
| Product Code | Device Name | Device Class | Medical Specialty |
|---|---|---|---|
| KFZ | Humidifier, Non-Direct Patient Interface (Home-Use) | FDA class 1 | Anesthesiology |
Similar 510(k) Clearances
Other 510(k) clearances with the same product code (KFZ), ordered by most recent decision date.
THERASTEAM PERSONAL STEAM INHALER
FDA 510(k)
FDA Class 1
·Anesthesiology
VIROTHERM HUMIDIFIER
FDA 510(k)
FDA Class 1
·Anesthesiology
RHINOTHERM ULTRA 2
FDA 510(k)
FDA Class 1
·Anesthesiology
WH150 ROOM HUMIDIFIER
FDA 510(k)
FDA Class 1
·Anesthesiology
SUNBEAM DURA-VAP WARM STEAM VAPORIZER MODEL 1380
FDA 510(k)
FDA Class 1
·Anesthesiology
TRANSPIRATOR(TM) MT-1000 PERSONAL HUMIDIFIER
FDA 510(k)
FDA Class 1
·Anesthesiology