The following data is part of a premarket notification filed by Eoshealth, Inc. with the FDA for In Touch Blood Glucose Monitoring System.
| Device ID | K133584 |
| 510k Number | K133584 |
| Device Name: | IN TOUCH BLOOD GLUCOSE MONITORING SYSTEM |
| Classification | Glucose Oxidase, Glucose |
| Applicant | EOSHEALTH, INC. 816 CONGRESS AVE, STE 1400 Austin, TX 78701 |
| Contact | Carrie Hetrick |
| Correspondent | Carrie Hetrick EOSHEALTH, INC. 816 CONGRESS AVE, STE 1400 Austin, TX 78701 |
| Product Code | CGA |
| Subsequent Product Code | JJX |
| Subsequent Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-11-21 |
| Decision Date | 2014-09-08 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00853553005417 | K133584 | 000 |
| 00853553005196 | K133584 | 000 |
| 00853553005189 | K133584 | 000 |
| 00853553005158 | K133584 | 000 |
| 00853553005141 | K133584 | 000 |
| 00853553005110 | K133584 | 000 |
| 00853553005097 | K133584 | 000 |
| 00853553005066 | K133584 | 000 |
| 00853553005059 | K133584 | 000 |
| 00853553005035 | K133584 | 000 |
| 00853553005028 | K133584 | 000 |
| 00853553005004 | K133584 | 000 |
| 00853553005011 | K133584 | 000 |
| 00853553005202 | K133584 | 000 |
| 00853553005219 | K133584 | 000 |
| 00853553005400 | K133584 | 000 |
| 00853553005349 | K133584 | 000 |
| 00853553005325 | K133584 | 000 |
| 00853553005318 | K133584 | 000 |
| 00853553005301 | K133584 | 000 |
| 00853553005295 | K133584 | 000 |
| 00853553005288 | K133584 | 000 |
| 00853553005271 | K133584 | 000 |
| 00853553005257 | K133584 | 000 |
| 00853553005240 | K133584 | 000 |
| 00853553005233 | K133584 | 000 |
| 00853553005226 | K133584 | 000 |
| 00853553005738 | K133584 | 000 |