The following data is part of a premarket notification filed by Honeywell Hommed, Llc with the FDA for Lifestream Management System, Lifestream Management Suite, Lifestream Patient Manager, Lifestream Manager, Lifestream Web Manager, Lifestream.
| Device ID | K153719 |
| 510k Number | K153719 |
| Device Name: | LifeStream Management System, LifeStream Management Suite, LifeStream Patient Manager, LifeStream Manager, LifeStream Web Manager, LifeStream |
| Classification | Transmitters And Receivers, Physiological Signal, Radiofrequency |
| Applicant | HONEYWELL HOMMED, LLC 3400 INTERTECH DR. SUITE 200 Brookfield, WI 53045 |
| Contact | Greg Lillegard |
| Correspondent | John Ziobro SPECTRAMEDEX, LLC 3215 GOLD ROAD Delafield, WI 53018 |
| Product Code | DRG |
| Subsequent Product Code | BZH |
| Subsequent Product Code | DPS |
| Subsequent Product Code | DQA |
| Subsequent Product Code | DXN |
| Subsequent Product Code | FLL |
| Subsequent Product Code | FRI |
| Subsequent Product Code | GJS |
| Subsequent Product Code | NBW |
| Subsequent Product Code | NXB |
| Subsequent Product Code | OUG |
| CFR Regulation Number | 870.2910 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-12-28 |
| Decision Date | 2016-06-03 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00817644020079 | K153719 | 000 |