The following data is part of a premarket notification filed by Honeywell Hommed, Llc with the FDA for Genesis Dm Model: 6053000a1.
| Device ID | K101242 |
| 510k Number | K101242 |
| Device Name: | GENESIS DM MODEL: 6053000A1 |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | HONEYWELL HOMMED, LLC 3400 INTERTECH DR. SUITE 200 Brookfield, WI 53045 |
| Contact | Emily Hei |
| Correspondent | Emily Hei HONEYWELL HOMMED, LLC 3400 INTERTECH DR. SUITE 200 Brookfield, WI 53045 |
| Product Code | DRG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-05-03 |
| Decision Date | 2010-06-11 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817644020123 | K101242 | 000 |
| 00817644020116 | K101242 | 000 |
| 00817644020048 | K101242 | 000 |