The following data is part of a premarket notification filed by American Healthcare Inc. with the FDA for Easygluco, Model Igm0002.
| Device ID | K031501 |
| 510k Number | K031501 |
| Device Name: | EASYGLUCO, MODEL IGM0002 |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | AMERICAN HEALTHCARE INC. 304 PARK AVENUE SOUTH SUITE 206 New York, NY 10010 |
| Contact | Edward Letco |
| Correspondent | Edward Letco AMERICAN HEALTHCARE INC. 304 PARK AVENUE SOUTH SUITE 206 New York, NY 10010 |
| Product Code | NBW |
| Subsequent Product Code | CGA |
| Subsequent Product Code | JJX |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-05-13 |
| Decision Date | 2003-10-16 |
| Summary: | summary |