FDA Registration
Active
🇺🇸 United States
SentrySuite Product Line 2.7
Reg #: 3033959233
·
FEI: 3033959233
·
Expires 2025
Products
4
Proprietary Names
1
Establishment Types
2
Classifications
4
Registration Details
- Registration Name
- Jaeger Medical America Inc.
- Registration Number
- 3033959233
- FEI Number
- 3033959233
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 14050 Rebecca St Bldg 4
- City
- Moreno Valley
- State
- CA
- ZIP
- 92553
- Country
- US
Regulatory Submissions
- 510(k) Number
- K122699
Owner / Operator
- Firm Name
- Jaeger Medical GmbH
- Operator Number
- 10092652
- Address
- Leibnizstrasse 7
- City
- Hoechberg
- State
- Bavaria
- Postal Code
- 97204
- Country
- DE
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Plethysmograph, Volume | JEH | Class 2 | Anesthesiology | No | 2025-02-03 |
| Calculator, Predicted Values, Pulmonary Function | BTY | Class 2 | Anesthesiology | No | 2025-02-03 |
| Spirometer, Diagnostic | BZG | Class 2 | Anesthesiology | No | 2025-02-03 |
| Calculator, Pulmonary Function Data | BZC | Class 2 | Anesthesiology | No | 2025-02-03 |
Proprietary Names
SentrySuite Product Line 2.7
Establishment Types
Repack or Relabel Medical Device
Complaint File Establishment per 21 CFR 820.198