PACETECH

FDA Device Registration & Listing · Clearwater, FL, US · Registration 3013314298

Public Record Device Listing Expiry Year: 2026 This page presents structured fields from public FDA datasets.

Registration Header Parameters

Normalized identity and public registration information from FDA records.

Source
FDA Device Registration & Listing
Record Type
Device registration/listing
Registration Number
3013314298
FEI Number
1051088
Entity Name
PACETECH
City/State/Country
Clearwater, FL, US
Establishment Address
515 S MLK JR AVE, Clearwater, FL 33756, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
PaceTech (Owner Number: 10084234)
Owner / Operator Contact Address
515 S MLK JR AVE, Clearwater, FL 33756, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K970445
PMA Number
N/A

All Registered Proprietary Names

Minipack/VitalMax

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
MHX Monitor, Physiological, Patient(With Arrhythmia Detection Or Alarms) Cardiovascular Class 2 870.1025 2024-01-29

Official Correspondent

Ilhan Bilgutay

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

PaceTech
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
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
K972535 Odam MAGLIFE C 1998-01-13
K170567 Remote Diagnostic Technologies , Ltd. Tempus Pro Patient Monitor 2017-07-06

Related Recall Records

Recall ID Recalling Firm Recall Class Product Description
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)]
Z-1729-2025 Remote Diagnostic Technologies Ltd. Farnborough Aerospace Centre Aerospace Boulevard Farnborough United Kingdom 2
Philips Tempus Pro Patient Monitor, REF: 00-1004-R, 00-1007-R, 00-1024-R, 00-1026-R, 00-1004, 00-1007

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 3013314298. Last updated year: 2026. Please use registration number 3013314298 when referencing this establishment in official correspondence.
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