FDA Registration
Active
🇺🇸 United States
ADVANCE IR TSCAN-450
Reg #: 3008956776
·
FEI: 3008956776
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- AMPHENOL THERMOMETRICS, INC.
- Registration Number
- 3008956776
- FEI Number
- 3008956776
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 967 WINDFALL RD
- City
- Saint Marys
- State
- PA
- ZIP
- 15857
- Country
- US
Regulatory Submissions
- 510(k) Number
- K081160
Owner / Operator
- Firm Name
- Amphenol Thermometrics, Inc.
- Operator Number
- 10052376
- Address
- 967 Windfall Road
- City
- Saint Marys
- State
- PA
- Postal Code
- 15857
- Country
- US
- Correspondent
- John R Lukie
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Continuous Measurement Thermometer | FLL | Class 2 | General Hospital | No | 2020-08-28 |
Proprietary Names
ADVANCE IR TSCAN-450
Establishment Types
Repack or Relabel Medical Device