FDA Registration
Active
🇺🇸 United States
Reprocessed Nellcor Pulse Oximeter Sensor
Reg #: 3030153385
·
FEI: 3030153385
·
Expires 2025
Products
1
Proprietary Names
1
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Stryker Sustainability Solutions - Chandler
- Registration Number
- 3030153385
- FEI Number
- 3030153385
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- Yes
- Address
- 6635 W Frye Rd
- City
- Chandler
- State
- AZ
- ZIP
- 85226
- Country
- US
Regulatory Submissions
- 510(k) Number
- K042316
Owner / Operator
- Firm Name
- STRYKER CORP.
- Operator Number
- 1811755
- Address
- 4100 East Milham Ave.
- City
- Kalamazoo
- State
- MI
- Postal Code
- 49001
- Country
- US
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Oximeter, Reprocessed | NLF | Class 2 | Cardiovascular | No | 2010-02-05 |
Proprietary Names
Reprocessed Nellcor Pulse Oximeter Sensor
Establishment Types
Reprocess Single-Use Device