FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SULLIVAN HUMIDAIRE HEATED HUMIDIFIER
K Number: K971260
·
Decision Sep 4, 1997
Classifications
1
FEI Numbers
108
Registration Numbers
108
Same Product Code
220
Applicant Total
17
Review Days
153
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Basic Information
- Device Name
- SULLIVAN HUMIDAIRE HEATED HUMIDIFIER
- K Number
- K971260
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5450
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Resmed Corp
- Date Received
- April 4, 1997
- Decision Date
- September 4, 1997
- 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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