FDA 510(k)
FDA class 2
Substantially Equivalent
🇮🇱 Israel
BB-613 Watch Oximeter
K Number: K181006
·
Decision Sep 21, 2018
Classifications
1
FEI Numbers
400
Registration Numbers
400
Same Product Code
725
Applicant Total
1
Review Days
158
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Basic Information
- Device Name
- BB-613 Watch Oximeter
- K Number
- K181006
- Device Class
- FDA class 2
- Clearance Type
- Traditional
- Regulation Number
- 870.2700
- Medical Specialty
- Cardiovascular
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Bio-Beat Technologies , Ltd.
- Date Received
- April 16, 2018
- Decision Date
- September 21, 2018
- 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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