The following data is part of a premarket notification filed by I-sens, Inc. with the FDA for Ketosens Bt Blood B-ketone Monitoring System.
| Device ID | K201551 |
| 510k Number | K201551 |
| Device Name: | KetoSens BT Blood B-Ketone Monitoring System |
| Classification | Nitroprusside, Ketones (urinary, Non-quant.) |
| Applicant | i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu Seoul, KR 06646 |
| Contact | Joon Ho Jung |
| Correspondent | Joon Ho Jung i-SENS, Inc. 43, Banpo-daero 28-gil, Seocho-gu Seoul, KR 06646 |
| Product Code | JIN |
| CFR Regulation Number | 862.1435 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-06-09 |
| Decision Date | 2020-09-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10885325001492 | K201551 | 000 |