FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OXYPULSE EOC I, EOC II & EOC R
K Number: K955129
·
Decision Feb 16, 1996
Classifications
1
FEI Numbers
17
Registration Numbers
17
Same Product Code
70
Applicant Total
3
Review Days
99
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Basic Information
- Device Name
- OXYPULSE EOC I, EOC II & EOC R
- K Number
- K955129
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.5905
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Statement
- Applicant
- Eagle Medical Equipment Co.
- Date Received
- November 9, 1995
- Decision Date
- February 16, 1996
- Product Code
- NFB
- 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 |
|---|---|---|---|
| NFB | Conserver, Oxygen | FDA class 2 | Anesthesiology |
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