Known Identifiers & Locations
FEI Numbers
N/A
Owner Operator Numbers
N/A
Locations Covered
N/A
Registered Establishments (0)
No device registration and listing records found for this entity.
510(k) Premarket Notifications (3)
| Submission # |
Device Name |
Decision Date |
Decision Description |
Action |
| K100940 |
FULLY AUTOMATIC ELECTRONIC BLOOD PRESSURE MONITOR, MODEL KD-5965 |
2010-06-29 |
Substantially Equivalent |
View Details
|
| K150833 |
iHealth Align Gluco-Monitoring System, iHealth BG5 wireless Smart Gluco-Monitoring System, iHealth BG5L wireless Smart Gluco-Monitoring System |
2015-12-04 |
Substantially Equivalent |
View Details
|
| K152003 |
iHealth BP3L Wireless Blood Pressure Monitor |
2015-09-24 |
Substantially Equivalent |
View Details
|
FDA Recall History (0)
No recall records found for this entity.
Profile Disclaimer
AvaSpecs compiles public data records from the FDA database. This compiled profile does not indicate endorsement, safety, clearance, approval, or compliance status. AvaSpecs is a private search index and is not affiliated with the FDA or any government agency.