FDA 510(k)
FDA class 1
Substantially Equivalent
🇹🇼 Taiwan
CARNATION - OXYGEN MASK
K Number: K851466
·
Decision Jun 19, 1985
Classifications
1
FEI Numbers
269
Registration Numbers
269
Same Product Code
54
Applicant Total
3
Review Days
69
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Basic Information
- Device Name
- CARNATION - OXYGEN MASK
- K Number
- K851466
- Device Class
- FDA class 1
- Clearance Type
- Traditional
- Regulation Number
- 868.5580
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Dadsun Corp., Ltd.
- Date Received
- April 11, 1985
- Decision Date
- June 19, 1985
- Product Code
- BYG
- 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 |
|---|---|---|---|
| BYG | Mask, Oxygen | FDA class 1 | Anesthesiology |
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