FDA Registration
Active
🇺🇸 United States
CLL-S700
Reg #: 3011050570
·
FEI: 3011050570
·
Expires 2025
Products
1
Proprietary Names
12
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Gyrus ACMI, Inc.
- Registration Number
- 3011050570
- FEI Number
- 3011050570
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 9600 Louisiana Ave North
- City
- Brooklyn Park
- State
- MN
- ZIP
- 55445
- Country
- US
Owner / Operator
- Firm Name
- OLYMPUS CORPORATION
- Operator Number
- 9067818
- Address
- 2951 ISHIKAWA-CHO
- City
- HACHIOJI-SHI
- State
- Tokyo
- Postal Code
- 192-8507
- Country
- JP
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Endoscopic Video Imaging System/Component, Gastroenterology-Urology | FET | Class 2 | Gastroenterology, Urology | No | 2021-07-29 |
Proprietary Names
CLL-S700
OTV-SI
CV-1500
OTV-S200
CH-S190-XZ-Q
CH-S700-XZ-EA
MAJ-2363
MAJ-2512
MAJ-2432
OTV-S300
MAJ-2511
OTV-S700
Establishment Types
Complaint File Establishment per 21 CFR 820.198