FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
NASAL OXYGEN CATHETER
K Number: K820370
·
Decision Apr 16, 1982
Classifications
1
FEI Numbers
36
Registration Numbers
36
Same Product Code
7
Applicant Total
64
Review Days
66
Basic Information
- Device Name
- NASAL OXYGEN CATHETER
- K Number
- K820370
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5350
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- American Pharmaseal Div. Ahsc
- Date Received
- February 9, 1982
- Decision Date
- April 16, 1982
- Product Code
- BZB
- 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 |
|---|---|---|---|
| BZB | Catheter, Nasal, Oxygen | FDA class 1 | Anesthesiology |
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