MODEL 5000 MULTIPLACE HYPERBARIC THERAPY
HYPERTEC, INC.
Hypertec HCM LLC
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3013896610 | 3013896610 | Hypertec HCM LLC | 1 | N | 2026-01-01 | 1570 Perry Road Plainfield IN US 46168 |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 211480 | 1961900679 | K230457 | Empatica Health Monitoring Platform; EmbracePlus; Empatica Care; Care Portal | MWI | 2023-10-30 |
| 211480 | 1445425478 | K221282 | Empatica Health Monitoring Platform | DQA | 2022-11-20 |
| 211480 | 1964326987 | K213863 | Everion+ System | MSX | 2023-02-23 |
| 211480 | 1989414554 | K191286 | CONTOUR® NEXT Blood Glucose Monitoring System, CONTOUR® NEXT USB Blood Glucose Monitoring System, CONTOUR® NEXT ONE Blood Glucose Monitoring System, CONTOUR® NEXT EZ Blood Glucose Monitoring System, CONTOUR® NEXT LINK Wireless Blood Glucose Monitoring System | NBW | 2019-11-08 |
| 211480 | 1334617176 | K183319 | Triangle System | DXH | 2019-05-10 |
| 211480 | 2020965329 | K183078 | VitalConnect Platform, VitalPatch Biosensor | DRG | 2019-03-07 |
| 211480 | 1522014599 | K170723 | Swaive Thermometer SWT1A | FLL | 2018-10-25 |
| 211480 | 1547606190 | K150052 | TRUE METRIX AIR Self-Monitoring Blood Glucose System, TRUE METRIX AIR PRO Professional Blood Gulcose Monitoring System | NBW | 2015-03-26 |
| 211480 | 2054204526 | K142642 | Vitalograph Model 6600 Compact | BZG | 2015-06-30 |
| 211480 | 1007481429 | K141542 | NELLCOR PORTABLE SPO2 PATIENT MONITORING SYSTEM ( NPSPMS ) | DQA | 2014-10-02 |
| 211480 | 1656204698 | K131021 | PULSE OXIMETER | DQA | 2013-09-11 |
| 211480 | 1107870926 | K081285 | FINGER PULSE OXIMETER, MODEL 9560 | DQA | 2008-06-05 |
| 211480 | 1304438593 | K043217 | A&D MEDICAL UA-767PBT DIGITAL BLOOD PRESSURE MONITOR | DXN | 2005-03-03 |
| 211480 | 1234264356 | ||||
| 211480 | 1953585252 | ||||
| 211480 | 1754876617 |
Product Codes Associated With Registrations#
PMN#
MODEL HYBRID 3200 MONOPLACE, HYPERBARIC THERAPY SYSTEMS
HYPERTEC, INC.