FDA 510(k)
FDA class 2
Unknown
🇺🇸 United States
CipherOx CRI Tablet
K Number: DEN160020
·
Decision Dec 21, 2016
Classifications
1
FEI Numbers
3
Registration Numbers
3
Same Product Code
7
Applicant Total
3
Review Days
211
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Basic Information
- Device Name
- CipherOx CRI Tablet
- K Number
- DEN160020
- Device Class
- FDA class 2
- Clearance Type
- Direct
- Regulation Number
- 870.2200
- Medical Specialty
- Cardiovascular
- Decision
- Unknown
- Applicant
- Flashback Technologies, Inc.
- Date Received
- May 24, 2016
- Decision Date
- December 21, 2016
- Product Code
- PPW
- 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 |
|---|---|---|---|
| PPW | Adjunctive Cardiovascular Status Indicator | FDA class 2 | Cardiovascular |
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