Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

THERMOMETER, EXACTA TEMP

K-Number: K781106 · 1978-08-10

ApplicantS.M.B. Celsius Co., Inc.
Decision Date1978-08-10
Product CodeFLK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THERMOMETER, EXACTA TEMP is the device name listed in this FDA 510(k) record. The listed applicant is S.M.B. Celsius Co., Inc.. It received FDA 510(k) clearance on 1978-08-10 under 510(k) number K781106. The device is classified under product code FLK. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THERMOMETER, EXACTA TEMP?

THERMOMETER, EXACTA TEMP is a medical device that received FDA 510(k) clearance on 1978-08-10. The listed applicant is S.M.B. Celsius Co., Inc.. The 510(k) number is K781106.

When did THERMOMETER, EXACTA TEMP receive FDA 510(k) clearance?

THERMOMETER, EXACTA TEMP received FDA 510(k) clearance on 1978-08-10, under 510(k) number K781106.

Who is the listed applicant for THERMOMETER, EXACTA TEMP?

The FDA 510(k) record lists S.M.B. Celsius Co., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERMOMETER, EXACTA TEMP?

The FDA product code for THERMOMETER, EXACTA TEMP is FLK.

Related Clinical Trials

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Related Devices (Code: FLK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

K960185AMSINO CLINICAL THERMOMETERAmsia Intl., Inc.K960224GERATHERM MERCUIRY FREE CLINICAL THERMOMETERRg Ent., Inc.K953465KENTEMPKentron Health Care, Inc.K942483CLINICAL GLASS THERMOMETERMakol Medical Instruments Corp.K941673MEDIAID UNIVERSAL THERMOMETERPolymedica Industries, Inc.K940394AMG MED BRAND CLINICAL GLASS THERMOMETERTechnolab Industries (Canada) , Ltd.

Official Source

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑