FDA Registration
Active
🇨🇦 Canada
989803183331 Multi Care Cuff, Small Adult
Reg #: 3000126629
·
FEI: 3000126629
·
Expires 2025
Products
1
Proprietary Names
14
Establishment Types
1
Classifications
1
Registration Details
- Registration Name
- Philips Electronics Ltd
- Registration Number
- 3000126629
- FEI Number
- 3000126629
- Status
- Active
- Expiry Year
- 2025
- Initial Importer
- No
- Address
- 1875 Buckhorn Gate, 5th Floor
- City
- Mississauga Ontario
- Country
- CA
Regulatory Submissions
- 510(k) Number
- K001333
Owner / Operator
- Firm Name
- Philips Medical Systems International BV
- Operator Number
- 1217116
- Address
- Veenpluis 6
- City
- Best
- State
- NL-NOTA
- Postal Code
- 5684PC
- Country
- NL
US Agent
- Business Name
- Philips
- Contact Name
- Shaylee Masilunas
- Address
- 6501 Living Place
- City
- Pittsburgh
- State
- PA
- ZIP
- 15206
- Country
- US
- [email protected]
- Phone
- 724 8162019
Products
| Device Name | Product Code | Device Class | Medical Specialty | Exempt | Created |
|---|---|---|---|---|---|
| Detector And Alarm, Arrhythmia | DSI | Class 2 | Cardiovascular | No | 2009-10-29 |
Proprietary Names
989803183331 Multi Care Cuff, Small Adult
989803183351 Multi Care Cuff, Adult XL
989803183371 Multi Care Cuff, Thigh
989803183321 Multi Care Cuff, Pediatric
989803183311 Multi Care Cuff, Infant
989803183341 Multi Care Cuff, Adult
989803183361Multi Care Cuff, Large Adult
M1574XL Comfort Care Cuff, Adult XL
M1574A Comfort Care Cuff, Adult
M1573A Comfort Care Cuff, Small Adult
M1575A Comfort Care Cuff, Large Adult
M1571A Comfort Care Cuff, Infant
M1572A Comfort Care Cuff, Pediatric
M1576A Comfort Care Cuff, Thigh
Establishment Types
Export Device to the United States But Perform No Other Operation on Device