FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NEBULIZER/HUMIDIFIER MODEL EH 147B
K Number: K781591
·
Decision Oct 16, 1978
Classifications
1
FEI Numbers
119
Registration Numbers
119
Same Product Code
19
Applicant Total
4
Review Days
28
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Basic Information
- Device Name
- NEBULIZER/HUMIDIFIER MODEL EH 147B
- K Number
- K781591
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5460
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Mistogen Equipment Co.
- Date Received
- September 18, 1978
- Decision Date
- October 16, 1978
- 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 |
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