FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
RESMED S8 PRIME CPAP SYSTEM
K Number: K033841
·
Decision Mar 10, 2004
Classifications
1
FEI Numbers
109
Registration Numbers
109
Same Product Code
449
Applicant Total
90
Review Days
91
Basic Information
- Device Name
- RESMED S8 PRIME CPAP SYSTEM
- K Number
- K033841
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- RESMED LTD.
- Date Received
- December 10, 2003
- Decision Date
- March 10, 2004
- Product Code
- BZD
- 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 |
|---|---|---|---|
| BZD | Ventilator, Non-Continuous (Respirator) | FDA class 2 | Anesthesiology |
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