Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source

FDA Device Registration & Listing

Record Type

Device registration/listing

Registration Number

3030597679

FEI Number

3030597679

Entity Name

HADLEIGH HEALTH TECHNOLOGIES

City/State/Country

Sausalito, CA, US

Establishment Address

200 Gate 5 Road, Suite 215, Sausalito, CA 94965, US

Establishment Type(s)

Develop Specifications But Do Not Manufacture At This Facility

Owner / Operator

Hadleigh Health Technologies (Owner Number: 10090336)

Owner / Operator Contact Address

200 Gate 5 Road, Suite 215, Sausalito, CA 94965, US

Initial Importer Flag

Expiration Date (Year)

2026

510(k) Number

K230298

PMA Number

N/A

All Registered Proprietary Names

Celsi Warmer Celsi Monitor

Registered Product Listings

Product Code	Device Name	Medical Specialty	Device Class	Regulation Number	Created Date
DWJ	System, Thermal Regulating	Cardiovascular	Class 2	870.5900	2025-07-03
MHX	Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms)	Cardiovascular	Class 2	870.1025	2024-03-13
FLL	Continuous Measurement Thermometer	General Hospital	Class 2	880.2910	2024-03-13

Official Correspondent

Margaret McCabe

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Hadleigh Health Technologies

View consolidated registration, premarket clearance, and recall records for this applicant.

View Entity Profile →

Related 510(k) Records

510(k) Number	Applicant	Device Name	Decision Date
K171373	3M Company	3M Bair Hugger Model 675 Total Temperature Management System	2017-10-10
K083336	Smiths Medical Asd, Inc.	LEVEL 1 SNUGGLE WARM ADULT UNDERBODY CONVECTIVE WARMING BLANKET, MODEL SW-2013, LEVEL 1 SNUGGLE WARM LEFT LATERAL	2009-06-03
K993974	Siemens Medical Solutions USA, Inc.	SIEMENS INFINITY SC 6002XL PORTABLE PATIENT MONITOR	2000-02-22
K182075	Shenzhen Mindray Bio-Medical Electronics Co., Ltd.	BeneVision N Series Patient Monitors (Including BeneVision N12, BeneVision N15, BeneVision N17, BeneVision N19. BeneVision N22, BeneVision N1)	2018-12-10
K051628	Draeger Medical Systems, Inc.	INFINITY MONITORS WITH SCIO MODIFICATIONS	2005-07-20

Related Recall Records

Recall ID	Recalling Firm	Recall Class	Product Description
Z-0035-2010	Cincinnati Sub-Zero Products Inc	2	WarmAir 135 Thermal Regulating System. Catalog Numbers: 86186-115 V, 06186-115 V (sold in the U.S.) and #86185-100 V ( not sold in the U.S.). Intended for warming patients before, during and after surgery, and other specialty procedures.
Z-0020-2025	Philips North America Llc	2	IntelliVue Patient Monitor MX400/MX450/MX500/MX550 with software version P.01.01 and ordered with Option CP2 are affected as follows: 1) IntelliVue MX400 866060; 2) IntelliVue MX450 866062; 3) IntelliVue MX500 866064; 4) IntelliVue MX550 866066 Indicated for use by health care professionals whenever there is a need for monitoring the physiological parameters of patients.
Z-1027-2026	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Philips Tempus Pro Patient Monitor, REF: 00-1004, 00-1007, 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R. USB 2-Channel IBP Module, REF: 01-2017. Used with User/Operator Manual
Z-1321-2023	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Tempus Pro Patient Monitor is a portable vital signs monitor intended to be used by clinicians and medically qualified personnel, for the attended or unattended monitoring of single or multiple vital signs in clinical and pre hospital care applications. The affected power supplies are related to the following Tempus Pro Patient Monitoring units: Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R Model Numbers: 00-1004 00-1004-R 00-1007 00-1007-R 00-1024-R 00-1026-R
Z-1666-2025	Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom	2	Tempus Pro Patient Monitor, REFs: 00-1004-R (Tempus Pro non-printer, IBP, without headset dock), 00-1007-R and 00-1007 (Tempus Pro non-printer, IBP, with headset dock), 00-1024-R (Tempus Pro printer), 00-1026-R (Tempus Pro printer, IBP), 00-1007 [(Tempus Pro, BT Dock (IB Only)], 00-1004 00-1004 [Tempus Pro (IB Only)]

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3030597679. Last updated year: 2026. Please use registration number 3030597679 when referencing this establishment in official correspondence.