Data / Medical devices / United States / Zoe Medical, Inc.

Zoe Medical, Inc.: FDA-registered device maker in Topsfield, MA, United States, 5 510(k) clearances

Name: Zoe Medical, Inc. FDA registration, clearances, approvals and recalls
Creator: SpecStream
License: https://creativecommons.org/licenses/by/4.0/

Zoe Medical, Inc. is registered with the FDA (registration 3003294644) in Topsfield, MA, United States. It lists 5 device types. The FDA files 5 510(k) clearances under its listings, the newest dated May 8, 2015. 3 recall events name it as the recalling firm. Registered through 2026. FDA data exported November 2, 2026.

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FDA registration number: 3003294644
Address: 460 Boston ST., Topsfield, MA, United States, 01983
Owner or operator: Zoe Medical, Inc (9041242)
Roles: Contract manufacturer, Manufacturer
First device listed: November 30, 2007
Registered through: 2026
Brand names listed: 740 Select, 91331 DM4, Midmark DVSD, Midmark IQvitals, Nightingale MPC, Nightingale Monitoring System, Nightingale PHM, Nightingale PPM and more

Devices it lists

Device	Product code	Class	Role	Source
Electrocardiograph	DPS	2	Contract manufacturer	accessdata.fda.gov
Monitor, Cardiac (Incl. Cardiotachometer & Rate Alarm)	DRT	2	Manufacturer	accessdata.fda.gov
Monitor, Physiological, Patient (Without Arrhythmia Detection Or Alarms)	MWI	2	Manufacturer	accessdata.fda.gov
Oximeter	DQA	2	Manufacturer	accessdata.fda.gov
System, Measurement, Blood-Pressure, Non-Invasive	DXN	2	Contract manufacturer, Manufacturer	accessdata.fda.gov

510(k) clearances

The 510(k) numbers this establishment lists, with the FDA decision on each. The applicant is the company that holds the clearance.

Decided	510(k) number	Device	Product code	Decision	Applicant	Source
May 8, 2015	K150620	740 SELECT	MWI	Substantially Equivalent	Cas Medical Systems, Inc.	accessdata.fda.gov
July 23, 2013	K130740	NIGHTINGALE MONITORING SYSTEM	MWI	Substantially Equivalent	Zoe Medical, Inc.	accessdata.fda.gov
April 9, 2010	K093802	ULTRAVIEW DM3 MONITOR	DXN	Substantially Equivalent	Zoe Medical, Inc.	accessdata.fda.gov
April 2, 2004	K040012	WELL@HOME SYSTEM	DXN	Substantially Equivalent	Zoe Medical, Inc.	accessdata.fda.gov
January 12, 2001	K001775	ZOE MEDICAL NIGHTINGALE MONITORING SYSTEM	DRT	Substantially Equivalent	Zoe Medical, Inc.	accessdata.fda.gov

Recalls

Recall events where this establishment is the recalling firm, matched on its FEI.

Initiated	Event	Class	Status	Product	Reason	Source
August 13, 2024	95160	Class II	Ongoing	Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330	This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life.	accessdata.fda.gov
June 6, 2012	62939	Class II	Terminated	Spacelabs Ultraview DM3 Monitor Model Number: 91330-NT The Ultraview DM3 Monitor is indicated for use by health care professionals for monitoring patient vital signs. The Ultraview DM3 Monitor is intended for monitoring,	Unit fails to power up, resulting in an equipment alarm	accessdata.fda.gov
February 2, 2009	55507	Not yet classified	Terminated	The Well@Home Monitor by Patient Care technologies Model Intended to be used as a clinical tool for remotely monitoring a patient's health status at home or in another healthcare facility on a spot check basis.	Touch panel may become unresponsive.	accessdata.fda.gov

Compare with other makers

Updated September 10, 2024. Read from openFDA bulk downloads (device registration and listing, 510(k), PMA, recall and enforcement files). CC0 1.0, public domain (openFDA terms of service). The files are joined on FDA identifiers: the 510(k) and PMA numbers a registration lists, and the recalling firm's FEI for recalls. Recall class comes from the FDA enforcement report. The FDA states that openFDA data is unvalidated and is not for decisions about medical care. Free to reuse with credit to SpecStream under CC BY 4.0. Spot a wrong value? Write to [email protected] with the link to this page.