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
Phone
724 8162019

Products

Device Name Product Code
Detector And Alarm, Arrhythmia DSI

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