The following data is part of a premarket notification filed by Honeywell Hommed Llc with the FDA for Hommed Central Station, Version 3.5.
| Device ID | K053453 |
| 510k Number | K053453 |
| Device Name: | HOMMED CENTRAL STATION, VERSION 3.5 |
| Classification | System, Measurement, Blood-pressure, Non-invasive |
| Applicant | HONEYWELL HOMMED LLC 2018 NORTH DURHAM DRIVE Houston, TX 77008 |
| Contact | Tommie J Morgan |
| Correspondent | Tommie J Morgan HONEYWELL HOMMED LLC 2018 NORTH DURHAM DRIVE Houston, TX 77008 |
| Product Code | DXN |
| CFR Regulation Number | 870.1130 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-12-12 |
| Decision Date | 2006-05-05 |
| Summary: | summary |