510(k) K193610
K193610 is an FDA 510(k) premarket notification submitted by Exalenz Bioscience , Ltd. for the device "BreathID Smart System". The FDA issued a decision of Substantially Equivalent on February 6, 2020. The device falls under product code MSQ (Test, Urea (Breath Or Blood)), a Class I device regulated under 21 CFR 866.3110. Exalenz Bioscience , Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 6, 2020
- Date Received
- December 26, 2019
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Test, Urea (Breath Or Blood)
- Device Class
- Class I
- Regulation Number
- 866.3110
- Review Panel
- MI
- Submission Type