FDA 510(k)
FDA class 2
Substantially Equivalent
🇩🇪 Germany
SMU 611 VERS. 2.0 INCLUDING PRESSNI,DILU,SAT-MOD.
K Number: K903900
·
Decision Jan 8, 1991
Classifications
1
FEI Numbers
97
Registration Numbers
97
Same Product Code
76
Applicant Total
3
Review Days
138
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Basic Information
- Device Name
- SMU 611 VERS. 2.0 INCLUDING PRESSNI,DILU,SAT-MOD.
- K Number
- K903900
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.1110
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Applicant
- Ppg Hellige B.V.
- Date Received
- August 23, 1990
- Decision Date
- January 8, 1991
- Product Code
- DSK
- Advisory Committee
- Cardiovascular
- Review Advisory Committee
- CV
- 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 |
|---|---|---|---|
| DSK | Computer, Blood-Pressure | FDA class 2 | Cardiovascular |
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