FDA 510(k)
FDA class 2
Substantially Equivalent
🇫🇮 Finland
SATLITE/PB251 PULSE OXIMETER
K Number: K870621
·
Decision Mar 20, 1987
Classifications
1
FEI Numbers
403
Registration Numbers
403
Same Product Code
711
Applicant Total
55
Review Days
36
Basic Information
- Device Name
- SATLITE/PB251 PULSE OXIMETER
- K Number
- K870621
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- DATEX DIVISION INSTRUMENTARIUM CORP.
- Date Received
- February 12, 1987
- Decision Date
- March 20, 1987
- Product Code
- DQA
- Advisory Committee
- Cardiovascular
- 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 |
|---|---|---|---|
| DQA | Oximeter | FDA class 2 | Cardiovascular |
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