FDA 510(k)
FDA class 2
Substantially Equivalent
🇬🇧 United Kingdom
Quantum Workstation 12.1
K Number: K181923
·
Decision Aug 17, 2018
Classifications
1
FEI Numbers
20
Registration Numbers
20
Same Product Code
46
Applicant Total
15
Review Days
30
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Basic Information
- Device Name
- Quantum Workstation 12.1
- K Number
- K181923
- Device Class
- FDA class 2
- Clearance Type
- Special
- Regulation Number
- 870.4330
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Spectrum Medical , Ltd.
- Date Received
- July 18, 2018
- Decision Date
- August 17, 2018
- Product Code
- DRY
- 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 |
|---|---|---|---|
| DRY | Monitor, Blood-Gas, On-Line, Cardiopulmonary Bypass | FDA class 2 | Cardiovascular |
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