The following data is part of a premarket notification filed by Honeywell Hommed, Llc with the FDA for Sentry Otc Monitor.
| Device ID | K061088 |
| 510k Number | K061088 |
| Device Name: | SENTRY OTC MONITOR |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| 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 | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2006-04-18 |
| Decision Date | 2006-06-09 |
| Summary: | summary |