510(k) K170463
K170463 is an FDA 510(k) premarket notification submitted by I-Sens, Inc. for the device "KetoSens Blood B-Ketone Monitoring System, KetoSens Multi Blood B-Ketone Monitoring System". The FDA issued a decision of Substantially Equivalent on April 13, 2018. The device falls under product code JIN (Nitroprusside, Ketones (Urinary, Non-Quant.)), a Class I device regulated under 21 CFR 862.1435. I-Sens, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 13, 2018
- Date Received
- February 15, 2017
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Nitroprusside, Ketones (Urinary, Non-Quant.)
- Device Class
- Class I
- Regulation Number
- 862.1435
- Review Panel
- CH
- Submission Type