Npac Multi-Use Ear Thermometer, Models TP 700, TP 702
by Norm Pacific Automation Corp.
510(k) K051835
Active
Valid until
No expiry
FDA recalls
None foundDocuments
Trust
Unverified
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK051835 | Date23 Sep 2005 | StatusActive |
Recalls
No FDA recalls found in the data synced 22 Oct 2026.
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not covered
United States — FDA 510(k) Active
Specification
- 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
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
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.