FDA Registration
Active
🇺🇸 United States
KOVEN TECHNOLOGY, INC.
Reg #: 1937397
·
FEI: 1937397
·
Expires 2026
Products
9
Proprietary Names
71
Establishment Types
4
Classifications
9
Registration Details
- Registration Name
- KOVEN TECHNOLOGY, INC.
- Registration Number
- 1937397
- FEI Number
- 1937397
- Status
- Active
- Expiry Year
- 2026
- Initial Importer
- Yes
- Address
- 477 N Lindbergh Blvd, SUITE 220
- City
- Saint Louis
- State
- MO
- ZIP
- 63141
- Country
- US
Regulatory Submissions
- 510(k) Number
- K143332
Owner / Operator
- Firm Name
- KOVEN TECHNOLOGY, INC.
- Operator Number
- 1937397
- Address
- 477 N. Lindbergh Blvd., STE 220
- City
- Saint Louis
- State
- MO
- Postal Code
- 63141
- Country
- US
- Correspondent
- HEATHER BELL
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Cart, Emergency, Cardiopulmonary (Excluding Equipment) | BZN | Class 1 | Anesthesiology | No | 2017-12-14 |
| Blood Pressure Cuff | DXQ | Class 2 | Cardiovascular | No | 2015-04-20 |
| Transducer, Ultrasonic | JOP | Class 2 | Cardiovascular | No | 2017-12-14 |
| Flowmeter, Blood, Cardiovascular | DPW | Class 2 | Cardiovascular | No | 2007-11-20 |
| System, Digital Image Communications, Radiological | LMD | Class 1 | Radiology | No | 2024-12-24 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2007-11-20 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2007-11-20 |
| Monitor, Ultrasonic, Nonfetal | JAF | Class 2 | Radiology | No | 2007-11-20 |
| System, Imaging, Pulsed Doppler, Ultrasonic | IYN | Class 2 | Radiology | No | 2007-11-20 |
Proprietary Names
CT-6
CT-XT
CT-4
CT-1
CT-2
CT-7
FAST Sphyg by Koven
Smartdop XT6
PG-01
Smartdop 30EX
PAUS2
HD307-8
HD307-20
HD307-10
AD8HD307
BiDop 3
PG-21
SmartVLiink
Smartdop XT
TP-01
PP8M05N5A
BT8M05S8A
P8M05S8A
P10M5S8A
T10M5S8C
BP5M05S8A
BF2M20S8A
BF8M15S8A
P5M05S8A
T2M20S8C
BT10M5S8C
T5M05S8C
BT2M20S8C
T8M05S8C
BP8M05S8A
BT5M05S8
BT8M05S8C
BT5M05S8A
BP10M5S8A
PP10M5N5A
VDP-8
VRP-08
NRP-10H
CRP-10H
NDP-10
NP20M12S8AF
HP20M1N5AF
FDP-8
HP10M2N5AF
CRP-20H
CRP-20H1N
NP20M12SF11
NP20M1S8A
NP10M2S8AF
VDP-08A
NRP-20H
LRP-08
ACP-08
NDP-20
VRP-20
Smartdop 45
ES100X
BiDop 7
ST2M25S8C
ST8M05S8C
PG-30
ST5M05S8C
ST8M05S8A
ST5M05S8A
ST10M5S8C
ES100VX
Establishment Types
Repack or Relabel Medical Device
Develop Specifications But Do Not Manufacture At This Facility
Manufacture Medical Device
Complaint File Establishment per 21 CFR 820.198