FDA Registration
Active
🇯🇵 Japan
IF-932P
Reg #: 3021736577
·
FEI: 3021736577
·
Expires 2025
Products
1
Proprietary Names
154
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Nihon Vinyl Cord Corporation - Kodama Second Factory
- Registration Number
- 3021736577
- FEI Number
- 3021736577
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1404-1 Kodama, Kodama-machi
- City
- Honjo-shi Saitama
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K151080
Owner / Operator
- Firm Name
- NIHON KOHDEN CORP.
- Operator Number
- 8030227
- Address
- 1-31-4 NISHIOCHIAI, SHINJUKU-KU
- City
- TOKYO
- State
- JP-13
- Postal Code
- 161-8560
- Country
- JP
US Agent
- Business Name
- Nihon Kohden America, LLC
- Contact Name
- Charlemagne Chua
- Address
- 15353 Barranca Parkway
- City
- Irvine
- State
- CA
- ZIP
- 92618
- Country
- US
- [email protected]
- Phone
- 949 3303964
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2015-12-28 |
Proprietary Names
IF-932P
TL-052S
YL-920P
DH-170P
JG-900P
YG-213T
JA-690PA
DM-190P
YS-108P1
YS-107P9
BR-906PA
YS-107P1
YS-107P4
JT-950P
AY-633P
YS-107P2
YN-925P
JL-639P
TL-631T1
YJ-910P
WS-960P
YS-106P4
TL-061S
YS-19003
YP-813P
JA-920P
A/CE620NK
QF-908P
JA-694PA
G9-KVM/ZA
IF-961P
YS-106P5
DM-191P
TL-273T3
YG-111T
YS-105P5
YS-108P2
TL-274T
AY-673P
A/EJ110-0010 Cable
IF-951P
QF-902P
QF-901P
QF-909P
IF-958P
YS-105P8
YP-814P
YP-815P
CU-192R
A/326391 Cable
YN-921P
YG-122T
IF-930P
TL-272T3
IF-919P
YN-920P
SC-170R
TG-970P
IF-946P
BSM-1733
QF-921P
TL-271T
IF-925P
IF-957P
YG-101T
AA-674P
AY-631P
JL-630P
JT-900P
SB-170P
YG-211T
LIFE SCOPE® G9
IF-935P
YN-901P
YS-106P6
YS-104P5
IF-942P
YS-105P6
BJ-900PA
YP-811P
IF-956P
IF-943P
IF-954P
BSM-1773
JP-900P
JP-910P
JP-920P
IF-923P
JL-650P
TL-274T3
TG-900P
YS-106P3
YN-900P
BSM-1753
IF-917P
IF-937P
JC-906PA
YP-812P
IF-913P
TL-220T
YS-094P2
YS-106P9
IF-19004
TL-271T3
A/646225 Cable
YN-990P
QF-907P
RY-910PA
IF-944P
YN-924P
TL-062S
AY-651P
TL-051S
YS-105P7
YP-810P
IF-914P
TL-535U
TL-272T
IF-920P
BR-903PA
YS-106P7
YJ-671P
IF-950P
TG-101T
IF-948P
YS-105P0
JL-500P1
JL-900P
TL-631T3
JL-631P
IF-928P
TL-273T
IF-922P
YJ-920P
QF-903P
AY-671P
SB-920P
JL-632P
YS-107P3
YP-817P
DZ-170P
IF-912P
YP-816P
QF-911P
IF-916P
IF-952P
TL-201T
YS-108P0
QF-801P
AY-653P
IF-963P
YS-106P8
TG-920P
Nihon Kohden CSM-1901 Bedside Monitor
Establishment Types
Manufacture Medical Device for Another Party (Contract Manufacturer)