zoemedical.com740 SafeSAT
Zoe Medical, Inc.
ZOE MEDICAL, INC.
FDA Registration(s)#
| Registration | FEI | Name | Status | Initial importer | Expiration year | Address |
|---|---|---|---|---|---|---|
| 3003294644 | 3003294644 | ZOE MEDICAL, INC. | 1 | N | 2026-01-01 | 460 BOSTON ST. TOPSFIELD MA US 01983 |
GUDID Contact Samples#
| Source GUDID | Product | Phone | |
|---|---|---|---|
| 00851920007170 | NA - ECG 3-Lead Set, 3 meter, Snap-on, AAMI. | 978-887-4013 | customersupport@zoemedical.com |
| 00851920007200 | NA - ECG 3-Lead Set, 1 meter, Snap-on, IEC. | 978-887-4013 | customersupport@zoemedical.com |
| 00851920007217 | NA - ECG 3-Lead Set, 1 meter, Snap-on, AAMI. | 978-887-4013 | customersupport@zoemedical.com |
Registered Device Listings#
| Registration key | Listing key | Premarket submission | Device | Product code | Decision date |
|---|---|---|---|---|---|
| 57534 | 1585008829 | K150620 | 740 SELECT | MWI | 2015-05-08 |
| 57534 | 1803481862 | K130740 | NIGHTINGALE MONITORING SYSTEM | MWI | 2013-07-23 |
| 57534 | 2024827882 | K093802 | ULTRAVIEW DM3 MONITOR | DXN | 2010-04-09 |
| 57534 | 1828546609 | K040012 | WELL@HOME SYSTEM | DXN | 2004-04-02 |
| 57534 | 1692502834 | K001775 | ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM | DRT | 2001-01-12 |
| 57534 | 1322328496 | ||||
| 57534 | 1746530000 |
Product Codes Associated With Registrations#
PMN#
NIGHTINGALE MONITORING SYSTEM
ZOE MEDICAL, INC.
ULTRAVIEW DM3 MONITOR
ZOE MEDICAL, INC.
WELL@HOME SYSTEM
ZOE MEDICAL, INC.
ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM
ZOE MEDICAL, INC.
GUDID#
NA - ECG 3-Lead Set, 3 meter, Snap-on, AAMI.
2016-09-22
NA - ECG 3-Lead Set, 1 meter, Snap-on, IEC.
2016-09-22
NA - ECG 3-Lead Set, 1 meter, Snap-on, AAMI.
2016-09-22
NA - ECG 3-Lead Set, 1 meter, Grabbers, AAMI.
2016-09-22
NA - ECG 3-Lead Set, 1 meter, Mini-grabbers, AAMI.
2017-01-28
NA - ECG 3-Lead Set, 1 meter, Mini-grabber, IEC.
2017-01-31
740 SELECT - The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
2022-09-27
740 SELECT - The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
2020-08-12
740 SELECT - The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
2020-08-12
740 SELECT - The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
2020-08-12
740 SELECT - The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
2020-05-04
DM4 - The DM4 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
2019-06-01
DM4 - The DM4 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
2019-06-01
DM4 - The DM4 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
2019-06-01
DM4 - The DM4 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
2019-06-01
740 SELECT - The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
2019-08-27
DM4 - The DM4 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
2019-06-15
DM4 - The DM4 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
2019-06-15
DM4 - The DM4 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
2019-06-15
DM4 - The DM4 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
2019-06-15
Ultraview DM3 - The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients.
2016-09-22
Ultraview DM3 - The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients.
2016-09-22
Ultraview DM3 - The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients.
2016-09-22
Ultraview DM3 - The Ultraview DM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients.
2016-09-22
Nightingale Monitoring System - The Nightingale PPM3 Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients.
2016-09-22
740 SELECT - The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
2016-09-22
740 SELECT - The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
2016-09-22
740 SELECT - The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
2016-09-22
740 SELECT - The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
2016-09-22
740 SELECT - The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
2016-09-22
740 SELECT - The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
2016-09-22
740 SELECT - The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
2016-09-22
740 SELECT - The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
2016-09-22
740 SELECT - The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
2016-09-22
740 SELECT - The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
2016-09-22
740 SELECT - The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
2016-09-22
740 SELECT - The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
2016-09-22
740 SELECT - The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
2016-12-23
740 SELECT - The 740 SELECT Monitor is intended for monitoring, recording, and alarming basic vital signs on adult and pediatric patients, including neonates.
2018-08-10
NA - ECG Intermediate Cable, 3-lead, 2 meter, AAMI/IEC
2021-05-10