Exergen Corporation

FDA Device Registration & Listing · Watertown, MA, US · Registration 1221195

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
1221195
FEI Number
1221195
Entity Name
Exergen Corporation
City/State/Country
Watertown, MA, US
Establishment Address
400 PLEASANT STREET, Watertown, MA 02472, US
Establishment Type(s)
Manufacture Medical Device
Owner / Operator
Exergen Corporation (Owner Number: 1221195)
Owner / Operator Contact Address
400 Pleasant Street, Watertown, MA 02472, US
Initial Importer Flag
N
Expiration Date (Year)
2026
510(k) Number
K882949
PMA Number
N/A

All Registered Proprietary Names

TemporalScanner various models Skin Temperature Scanner models Ear/Tympanic thermometer models

Registered Product Listings

Product Code Device Name Medical Specialty Device Class Regulation Number Created Date
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-04-29
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-05-02
FLL Continuous Measurement Thermometer General Hospital Class 2 880.2910 2008-05-02

Official Correspondent

FRANCESCO POMPEI

US Agent Details

No US Agent registered (Local establishment).

Related Public Records

Same Entity

Exergen Corporation
View consolidated registration, premarket clearance, and recall records for this applicant.
View Entity Profile →

Other Registrations for Same Entity

Registration Number Establishment Name Location
3017581269 Exergen Corporation Leominster Warehouse Leominster, MA, US

Related 510(k) Records

510(k) Number Applicant Device Name Decision Date
K010462 Avita Corporation AVITA PICCOLO/EXATO INFARED EAR THERMOMETER (TS2 & TS4 SERIES) 2001-04-11
K760421 Arbrook Mfg. Corp. THERMOMETER, SURVALENT-ELECTRONIC 1976-08-23
K813409 Yellow Springs Instrument Co., Inc. MODEL 2100 DUAL-DISPLAY TELE-THERMOMETER 1981-12-18
K830039 Science Development Corp. SDC RECTAL TEMP. PROBE PRODUCT #1020 1983-02-23
K842199 Sharp Electronics Corp. ELEC. DIGITAL THERMOMETER MT-20 & 30 1984-07-18

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Source Citation & Summary: This public preview is extracted from openFDA device registration and listing logs under registration number 1221195. Last updated year: 2026. Please use registration number 1221195 when referencing this establishment in official correspondence.
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