The following data is part of a premarket notification filed by Honeywell Hommed, Llc with the FDA for Genesis Otc Monitor.
Device ID | K061087 |
510k Number | K061087 |
Device Name: | GENESIS 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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
00817644020109 | K061087 | 000 |
00817644020093 | K061087 | 000 |
00817644020086 | K061087 | 000 |