The following data is part of a premarket notification filed by Honeywell Hommed, Llc with the FDA for Genesis Touch System.
| Device ID | K112858 |
| 510k Number | K112858 |
| Device Name: | GENESIS TOUCH SYSTEM |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | HONEYWELL HOMMED, LLC 3400 INTERTECH DR. SUITE 200 Brookfield, WI 53045 |
| Contact | Claudia Jackson |
| Correspondent | Claudia Jackson HONEYWELL HOMMED, LLC 3400 INTERTECH DR. SUITE 200 Brookfield, WI 53045 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2011-09-30 |
| Decision Date | 2012-01-24 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817644020055 | K112858 | 000 |
| 00817644020031 | K112858 | 000 |
| 00817644020024 | K112858 | 000 |
| 00817644020017 | K112858 | 000 |