FDA 510(k)
FDA class 2
Substantially Equivalent
🇺🇸 United States
OXYMETER
K Number: K800631
·
Decision Apr 2, 1980
Classifications
1
FEI Numbers
18
Registration Numbers
18
Same Product Code
46
Applicant Total
3
Review Days
13
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Basic Information
- Device Name
- OXYMETER
- K Number
- K800631
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 868.2500
- Medical Specialty
- Anesthesiology
- Decision
- Substantially Equivalent
- Applicant
- Dragerwerk AG
- Date Received
- March 20, 1980
- Decision Date
- April 2, 1980
- Product Code
- KLK
- 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 |
|---|---|---|---|
| KLK | Monitor, Oxygen, Cutaneous, For Infant Not Under Gas Anesthesia | FDA class 2 | Anesthesiology |
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