510(K) CLEARANCES 84 ▲14RECALLS POSTED 39 ▲27CLASS I 6 ▲2PMA DECISIONS 47 ▲11WEEK ENDING / FDA DATA AS OF
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Zoe Medical, Inc.

Topsfield, MA, US

ZOE MEDICAL, INC. appears in FDA device records in Topsfield, MA. FDA records list 5 510(k) clearances between and , no PMA records and one registered establishment. As of , FDA records show 4 recalls for this company, and at least one establishment registration is current.

FDA records held for this company

510(k) clearances
5
PMA records
0
Recall records
4
Registered establishments
1

FDA records under these names

1 name

FDA records resolved to Zoe Medical, Inc. carry these names as well, as FDA wrote them. Each is the firm named on a registration, a 510(k), a PMA, a recall or an enforcement report that was joined to this company on a shared FDA identifier or on a matching name.

  • Zoe Medical Incorporatedenforcement report, recall

510(k) clearance history

FDA records hold 5 510(k) clearances for Zoe Medical, Inc. between 2001 and 2021. The busiest year on record is 2001, with 1. The most recent is 2021, with 1.

Clearances by year, as a table
510(k) clearance decisions for Zoe Medical, Inc., by decision year
YearClearances
20011
20041
20101
20131
20211
510(k) clearances on record, most recent first
K numberDeviceProduct codeDecisionDecision date
K200160740 SafeSATMWISubstantially Equivalent
K130740NIGHTINGALE MONITORING SYSTEMMWISubstantially Equivalent
K093802ULTRAVIEW DM3 MONITORDXNSubstantially Equivalent
K040012WELL@HOME SYSTEMDXNSubstantially Equivalent
K001775ZOE MEDICAL NIGHTINGALE MONITORING SYSTEMDRTSubstantially Equivalent

Registered establishments

FDA registered establishments for Zoe Medical, Inc., with the product codes listed at each
RegistrationFEIEstablishmentAddressRegistration expiresProduct codes listed
30032946443003294644ZOE MEDICAL, INC.460 BOSTON ST., TOPSFIELD, MA 01983 US2026

Registration numbers link to the FDA registration and listing record for that establishment.

FDA product codes

Recall records

Device recall records naming this company, most recent first
RecallProductReasonClassificationInitiatedStatus
Z-3099-2024Spacelabs Ultraview DM4 Vital Signs Monitor (all variations -M, -N, -MF, -NF, -MW, -NW, -MFW, -NFW), Model Number 91331This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life.Class IIOpen, Classified
Z-3098-2024Spacelabs Ultraview DM3 Vital Signs Monitor (all variations -M, -MT, -N, -NT), Model Number 91330This product labeling does not adequately provide warning about the risks associated with the use of damaged batteries or batteries past the intended use life.Class IIOpen, Classified
Z-2380-2012Spacelabs 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, recording, and alarming basic vital signs on adult and pediatric patients. Monitored parameters include SpO2, pulse rate, NIBP, and temperature.Unit fails to power up, resulting in an equipment alarmClass IITerminated
Z-2166-2010The Well@Home Monitor by Patient Care technologies Model 179-2150 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.Terminated

Verification record

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Data as of , FDA export datePage updated Source: openFDA, public domain