The following data is part of a premarket notification filed by Genesis Health Technologies with the FDA for Genesis Health Record System, (ghrs).
| Device ID | K123136 |
| 510k Number | K123136 |
| Device Name: | GENESIS HEALTH RECORD SYSTEM, (GHRS) |
| Classification | System, Test, Blood Glucose, Over The Counter |
| Applicant | GENESIS HEALTH TECHNOLOGIES P.O. OX 2042 Fairfield, IA 52556 |
| Contact | Kathleen Johnson |
| Correspondent | Kathleen Johnson GENESIS HEALTH TECHNOLOGIES P.O. OX 2042 Fairfield, IA 52556 |
| Product Code | NBW |
| CFR Regulation Number | 862.1345 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2012-10-05 |
| Decision Date | 2013-03-07 |
| Summary: | summary |