The following data is part of a premarket notification filed by Mennen Medical, Inc. with the FDA for Horizon 2000 Non-invasive Blood Pressure Cap..
| Device ID | K854942 |
| 510k Number | K854942 |
| Device Name: | HORIZON 2000 NON-INVASIVE BLOOD PRESSURE CAP. |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Contact | Ronald A Widman |
| Correspondent | Ronald A Widman MENNEN MEDICAL, INC. 10123 MAIN ST. Clarence, NY 14031 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-12-10 |
| Decision Date | 1986-06-02 |