FDA 510(k)
FDA class 1
Substantially Equivalent
🇮🇱 Israel
BreathID Smart System
K Number: K193610
·
Decision Feb 6, 2020
Classifications
1
FEI Numbers
1
Registration Numbers
1
Same Product Code
16
Applicant Total
5
Review Days
42
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Basic Information
- Device Name
- BreathID Smart System
- K Number
- K193610
- Device Class
- FDA class 1
- Clearance Type
- Special
- Regulation Number
- 866.3110
- Medical Specialty
- Microbiology
- Decision
- Substantially Equivalent
- Statement or Summary
- Summary
- Applicant
- Exalenz Bioscience , Ltd.
- Date Received
- December 26, 2019
- Decision Date
- February 6, 2020
- Product Code
- MSQ
- Advisory Committee
- Microbiology
- Review Advisory Committee
- MI
- 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 |
|---|---|---|---|
| MSQ | Test, Urea (Breath Or Blood) | FDA class 1 | Microbiology |
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