The following data is part of a premarket notification filed by Maxi-aids, Inc. with the FDA for Reizen Talking Blood Pressure Monitor, Model #sf860t.
| Device ID | K041778 |
| 510k Number | K041778 |
| Device Name: | REIZEN TALKING BLOOD PRESSURE MONITOR, MODEL #SF860T |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | MAXI-AIDS, INC. 42 EXECUTIVE BLVD. Farmingdale, NY 11735 |
| Contact | Elliot Zaretsky |
| Correspondent | Elliot Zaretsky MAXI-AIDS, INC. 42 EXECUTIVE BLVD. Farmingdale, NY 11735 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Abbreviated |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-07-01 |
| Decision Date | 2004-08-31 |
| Summary: | summary |