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Npac Multi-Use Ear Thermometer, Models TP 700, TP 702

by Norm Pacific Automation Corp.

510(k) K051835

Active United States

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

None found

in data synced 22 Oct 2026

Documents

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source FDA 510(k), synced 22 Oct 2026. What this means

Regulatory status

as of registry sync 22 Oct 2026

RegionAuthorizationNumberDateStatus
United StatesFDA 510(k)SESE Substantially Equivalent · Special NumberK051835 Date23 Sep 2005ClearedStatusActive

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 22 Oct 2026.

Coverage

1 jurisdiction

United States of America
  • Active
  • Expiring
  • Withdrawn
  • Listed
  • Not covered

United States — FDA 510(k) Active

Specification

510(k)

510(k) Number
FDA Product Code
FLL
Device Class
Class II
Regulation
21 CFR Part 880.2910
Advisory Committee
General Hospital
FDA Decision
SESE Substantially Equivalent

Overview

AI-generated summary, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

The Npac Multi-Use Ear Thermometer is an electronic clinical thermometer designed for home use. It measures infrared energy emitted from the ear canal and eardrum, converting thermal radiation into a digital temperature reading. This device can be operated by patients or caregivers to provide intermittent temperature monitoring.

The thermometer is supplied as a multi-use device and is classified under product code FLL with FDA 510K clearance K051835. It received a substantially equivalent decision on September 23, 2005, and is reviewed under the General Hospital advisory committee. The device is intended for general hospital use and falls under class 2 regulation 880.2910 for continuous measurement thermometers.

Other devices from Norm Pacific Automation Corp.

Questions

AI-generated answers, 26 Sep 2026

Written by a language model from registry data. Not verified by deviCERTS or the manufacturer. The registry data above is the record.

  • What is the NPAC Multi-Use Ear Thermometer designed for?

    The NPAC Multi-Use Ear Thermometer is an electronic clinical thermometer designed for home use. It measures infrared energy emitted from the ear canal and eardrum, converting thermal radiation into a digital temperature reading that can be operated by patients or caregivers.

  • How is the NPAC Ear Thermometer supplied and can it be reused?

    The thermometer is supplied as a multi-use device, meaning it can be used multiple times rather than being disposable. It is intended for general hospital use and requires proper cleaning and maintenance between uses to ensure accurate readings.

  • What are the regulatory specifications for this thermometer?

    The NPAC Multi-Use Ear Thermometer is classified under product code FLL with FDA 510K clearance K051835. It received a substantially equivalent decision on September 23, 2005, and is reviewed under the General Hospital advisory committee, falling under class 2 regulation 880.2910 for continuous measurement thermometers.

  • What models are available in the NPAC Multi-Use Ear Thermometer series?

    The NPAC Multi-Use Ear Thermometer is available in two models: TP 700 and TP 702. Both models function similarly as electronic clinical thermometers designed for home use, measuring infrared energy from the ear canal to provide temperature readings.