FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
HYMIDIFIER
K Number: K780088
·
Decision Feb 2, 1978
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
220
Applicant Total
331
Review Days
20
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Basic Information
- Device Name
- HYMIDIFIER
- K Number
- K780088
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5450
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- 3M Company
- Date Received
- January 13, 1978
- Decision Date
- February 2, 1978
- Product Code
- BTT
- 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 |
|---|---|---|---|
| BTT | Humidifier, Respiratory Gas, (Direct Patient Interface) | FDA class 2 | Anesthesiology |
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FDA 510(k)
FDA Class 2
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