The following data is part of a premarket notification filed by Lifescan, Inc. with the FDA for Harmony Inr Monitoring System.
| Device ID | K022922 |
| 510k Number | K022922 |
| Device Name: | HARMONY INR MONITORING SYSTEM |
| Classification | Test, Time, Prothrombin |
| Applicant | LIFESCAN, INC. 1000 GIBRALTAR DR. Milpitas, CA 95035 -6312 |
| Contact | John E Hughes |
| Correspondent | John E Hughes LIFESCAN, INC. 1000 GIBRALTAR DR. Milpitas, CA 95035 -6312 |
| Product Code | GJS |
| CFR Regulation Number | 864.7750 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-09-04 |
| Decision Date | 2002-09-30 |
| Summary: | summary |