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Pace Tech, Inc.

Also registered as PACETECH

United StatesFDA applicant, unverified

Devices
18

What Pace Tech, Inc. makes

Pace Tech, Inc. manufactures portable and non-invasive patient monitoring devices, including pulse oximeters (e.g., OXIMAX 700, OXIMAX 100) and vital sign monitors (e.g., VITALMAX 4000, VITALMAX 800 series). The company also produces compact medical packs (e.g., MINIPACK 911-STC, HANDYPACK 911SC) and standalone monitoring systems like the VITAL SYSTEM. Devices are designed for real-time monitoring of oxygen saturation, pulse, and other vital signs in clinical and pre-hospital settings.

The company’s devices are classified as Class II under FDA regulations and are listed via the 510(k) clearance pathway. These products are intended for use in the United States and comply with applicable FDA requirements for medical device authorisation. No additional registries or international listings are specified.

AI-generated from registry data, 2 Oct 2026. Not verified by deviCERTS or the manufacturer.

Catalogue18

Newest first, rows 1-18 of 18

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  • Vitalmax 4000 Ref K933624

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vitalmax 830 Series Ref K913263

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Oximax 700 Ref K900866

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Minipack 911-Stc Ref K925701

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vitalmax 4100 Ref K953795

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Handypack 911SC Ref K944541

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vitalmax 800-C Ref K930559

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vitalmax 510/520 Ref K912880

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vitalmax 2100/2200 Ref K905274

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vital System Ref K880351

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vitalmax 800 Non-Invasive Vital Sign Monitor/Pulse Ref K900451

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Oximax 100 Ref K900843

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Mini-Pack 911 Series Ref K912835

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vitalmax 500 Pulse Oximeter W/Temp. And Respira. Ref K901066

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vitalmax 2000 Ecg Monitor W/Non-Invasive Blood-Pre Ref K901612

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Minipack 3100/3000 Modification Ref K934385

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vitalmax 800 Plus/Vitalmax 810 Plus/Minipack 300 Ref K945385

    Active Regimes: 510(k) Registry: 510(k) Class:II

  • Vitalmax 4000/Minipack 3100/3000 Ref K951226

    Active Regimes: 510(k) Registry: 510(k) Class:II

Rows 1-18 of 18

Frequently asked questions

How many devices does Pace Tech, Inc. have in the registry?

The registry currently lists 18 devices for Pace Tech, Inc.. Devices recorded under merged duplicate company entries are counted once.

Which registries list Pace Tech, Inc.'s devices?

Among its 18 most recently registered devices, Pace Tech, Inc. has devices listed in FDA 510(k) (18 devices).

What risk classes do Pace Tech, Inc.'s devices fall under?

Among its 18 most recently registered devices, the classes recorded for Pace Tech, Inc.'s devices are Class II. Each device page shows its own class and authorisation.

What are the newest devices from Pace Tech, Inc. in the registry?

The most recently registered devices listed for Pace Tech, Inc. include VITALMAX 4000, VITALMAX 830 SERIES, OXIMAX 700 and MINIPACK 911-STC.

Generated automatically from registry data and not verified by a human reviewer.