The following data is part of a premarket notification filed by Genexel Medical Instrument Inc with the FDA for Forecare Advanced Sport Wrist Blood Pressure Monitor, Model Fp-0217.
| Device ID | K092061 |
| 510k Number | K092061 |
| Device Name: | FORECARE ADVANCED SPORT WRIST BLOOD PRESSURE MONITOR, MODEL FP-0217 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | GENEXEL MEDICAL INSTRUMENT INC 845 ARONSON LAKE COURT Roswell, GA 30075 |
| Contact | Jay Mansour |
| Correspondent | Jay Mansour GENEXEL MEDICAL INSTRUMENT INC 845 ARONSON LAKE COURT Roswell, GA 30075 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-07-08 |
| Decision Date | 2010-03-26 |
| Summary: | summary |