FDA 510(k)
FDA class 1
Substantially Equivalent
🇺🇸 United States
OXYGEN/NITROUS OXIDE OUTLET
K Number: K780365
·
Decision Mar 30, 1978
Classifications
1
FEI Numbers
21
Registration Numbers
21
Same Product Code
7
Applicant Total
3
Review Days
24
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Basic Information
- Device Name
- OXYGEN/NITROUS OXIDE OUTLET
- K Number
- K780365
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.6885
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Spica, Inc.
- Date Received
- March 6, 1978
- Decision Date
- March 30, 1978
- Product Code
- CAM
- 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 |
|---|---|---|---|
| CAM | Yoke Assembly, Medical Gas | FDA class 1 | Anesthesiology |
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