IVAC Model 2090 Infra Red Thermometer
by Y 510(k)
Active
510(k) K896914
Overview
The IVAC Model 2090 Infra Red Thermometer is a continuous measurement thermometer classified under product code FLL. It is designed for non-contact temperature measurement using infrared technology.
This device is supplied as a reusable instrument intended for use in general hospital settings. It received FDA 510(k) clearance (K896914) on March 2, 1990, following a traditional review process and was found substantially equivalent to a predicate device.
Regulatory status
| Region | Authorization | Number | Date | Status |
|---|---|---|---|---|
| United States | FDA 510(k)SESE | NumberK896914 | Date2 Mar 1990 | StatusActive |
Coverage
- Active
- Expiring
- Withdrawn
- Listed
- Not known
- Not covered
United States — FDA 510(k) Active
Recalls
No FDA recalls on record, checked 22 Oct 2026.
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
Other devices from Y
Questions
What is the IVAC Model 2090 Infrared Thermometer used for?
The IVAC Model 2090 Infrared Thermometer is designed for non-contact temperature measurement using infrared technology, intended for use in general hospital settings as a continuous measurement thermometer.
Is the IVAC Model 2090 Infrared Thermometer reusable or single-use?
The IVAC Model 2090 Infrared Thermometer is supplied as a reusable instrument, meaning it is intended for multiple uses after appropriate cleaning and disinfection in accordance with hospital protocols.
What regulatory clearance does the IVAC Model 2090 Infrared Thermometer have?
The IVAC Model 2090 Infrared Thermometer received FDA 510(k) clearance (K896914) on March 2, 1990, following a traditional review process and was found substantially equivalent to a predicate device.