FDA Registration
Active
🇯🇵 Japan
KD-V611M-07302A
Reg #: 8010047
·
FEI: 3002807795
·
Expires 2025
Products
1
Proprietary Names
20
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- OLYMPUS MEDICAL SYSTEMS CORP.
- Registration Number
- 8010047
- FEI Number
- 3002807795
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 2951 ISHIKAWA-CHO
- City
- HACHIOJI-SHI Tokyo
- Country
- JP
Regulatory Submissions
- 510(k) Number
- K122505
Owner / Operator
- Firm Name
- OLYMPUS CORPORATION
- Operator Number
- 9067818
- Address
- 2951 ISHIKAWA-CHO
- City
- HACHIOJI-SHI
- State
- Tokyo
- Postal Code
- 192-8507
- Country
- JP
US Agent
- Business Name
- Gyrus ACMI, Inc.
- Contact Name
- Todd Brill
- Address
- 800 West Park Drive, --
- City
- Westborough
- State
- MA
- ZIP
- 01581
- Country
- US
- [email protected]
- Phone
- 508 2077661
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Unit, Electrosurgical, Endoscopic (With Or Without Accessories) | KNS | Class 2 | Gastroenterology, Urology | No | 2013-06-25 |
Proprietary Names
KD-V611M-07302A
KD-V631M-07302A
KD-V611M-07252S
KD-V611M-07301A
KD-V611M-07201S
KD-V611M-07251A
KD-V611M-07301S
KD-V611M-07201A
KD-V631M-07201A
KD-V631M-07301A
KD-V631M-07202S
KD-V611M-07302S
KD-V631M-07301S
KD-V631M-07201S
KD-V611M-07202A
KD-V611M-07251S
KD-V631M-07302S
KD-V611M-07252A
KD-V631M-07202A
KD-V611M-07202S
Establishment Types
Develop Specifications But Do Not Manufacture At This Facility