FDA Registration
Active
🇬🇧 United Kingdom
REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
Reg #: 3003832357
·
FEI: 3003832357
·
Expires 2025
Products
14
Proprietary Names
0
Establishment Types
2
Classifications
14
Registration Details
- Registration Name
- REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
- Registration Number
- 3003832357
- FEI Number
- 3003832357
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- ASCENT 1, FARNBOROUGH AEROSPACE CENTRE, AEROSPACE BOULEVARD
- City
- FARNBOROUGH Hampshire
- Country
- GB
Regulatory Submissions
- 510(k) Number
- K173768
Owner / Operator
- Firm Name
- REMOTE DIAGNOSTIC TECHNOLOGIES LTD.
- Operator Number
- 9044740
- Address
- ASCENT 1, FARNBOROUGH AEROSPACE CENTRE, AEROSPACE BOULEVARD
- City
- FARNBOROUGH
- State
- Hampshire
- Postal Code
- GU14 6XW
- Country
- GB
- Correspondent
- Rodolfo - Carollo
US Agent
- Business Name
- PHILIPS
- Contact Name
- Tami Tuttle
- Address
- 22100 BOTHELL EVERETT HIGHWAY
- City
- Bothell
- State
- WA
- ZIP
- 98021
- Country
- US
- [email protected]
- Phone
- 720 6821456
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter | DQA | Class 2 | Cardiovascular | No | 2018-01-12 |
| Transducer, Ultrasonic, Diagnostic | ITX | Class 2 | Radiology | No | 2018-01-12 |
| Ventilatory Effort Recorder | MNR | Class 2 | Anesthesiology | No | 2018-01-12 |
| Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms) | MWI | Class 2 | Cardiovascular | No | 2018-01-12 |
| Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) | MHX | Class 2 | Cardiovascular | No | 2018-01-12 |
| Dislodger, Stone, Basket, Ureteral, Metal | FFL | Class 2 | Gastroenterology, Urology | No | 2018-01-12 |
| Analyzer, Gas, Carbon-Dioxide, Gaseous-Phase | CCK | Class 2 | Anesthesiology | No | 2018-01-12 |
| Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm) | DRT | Class 2 | Cardiovascular | No | 2018-01-12 |
| Transmitters And Receivers, Physiological Signal, Radiofrequency | DRG | Class 2 | Cardiovascular | No | 2018-01-12 |
| System, Measurement, Blood-Pressure, Non-Invasive | DXN | Class 2 | Cardiovascular | No | 2018-01-12 |
| Electrocardiograph | DPS | Class 2 | Cardiovascular | No | 2018-01-12 |
| Plethysmograph, Impedance | DSB | Class 2 | Cardiovascular | No | 2018-01-12 |
| Computer, Blood-Pressure | DSK | Class 2 | Cardiovascular | No | 2018-01-12 |
| System, Imaging, Pulsed Echo, Ultrasonic | IYO | Class 2 | Radiology | No | 2018-01-12 |
Establishment Types
Complaint File Establishment per 21 CFR 820.198
Manufacture Medical Device