FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM
K Number: K974417
·
Decision Jun 24, 1998
Classifications
1
FEI Numbers
33
Registration Numbers
33
Same Product Code
46
Applicant Total
17
Review Days
212
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Basic Information
- Device Name
- SULLIVAN VPAP II ST-A NASAL VPAP SYSTEM
- K Number
- K974417
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5895
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Resmed Corp
- Date Received
- November 24, 1997
- Decision Date
- June 24, 1998
- Product Code
- MNS
- 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 |
|---|---|---|---|
| MNS | Ventilator, Continuous, Non-Life-Supporting | FDA class 2 | Anesthesiology |
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