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 |