FDA Registration
Active
🇺🇸 United States
Fukuda Denshi DynaScope 7000 Series Patient Monito
Reg #: 3031158
·
FEI: 3000215024
·
Expires 2025
Products
8
Proprietary Names
1
Establishment Types
1
Classifications
8
Registration Details
- Registration Name
- FUKUDA DENSHI USA, INC.
- Registration Number
- 3031158
- FEI Number
- 3000215024
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 17725 N.E. 65TH ST., BLDG. C
- City
- REDMOND
- State
- WA
- ZIP
- 98052
- Country
- US
Regulatory Submissions
- 510(k) Number
- K083697
Owner / Operator
- Firm Name
- FUKUDA DENSHI CO., LTD.
- Operator Number
- 9028352
- Address
- 3-39-4, HONGO, BUNKYO-KO, --
- City
- TOKYO
- State
- JP-NOTA
- Postal Code
- 113
- Country
- JP
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2009-12-10 |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | Class 2 | Gastroenterology, Urology | No | 2009-12-10 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2009-12-10 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2009-12-10 |
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2009-12-10 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2009-12-10 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2009-12-10 |
| Monitor, Breathing Frequency | BZQ | Class 2 | Anesthesiology | No | 2009-12-10 |
Proprietary Names
Fukuda Denshi DynaScope 7000 Series Patient Monito
Establishment Types
Complaint File Establishment per 21 CFR 820.198