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FDA 510(k)

THERMOMETER (MADE IN CHINA)

K-Number: K811631 · 1981-07-20

ApplicantRobert I. Chien & Assoc., Inc.
Decision Date1981-07-20
Product CodeFLK
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

THERMOMETER (MADE IN CHINA) is the device name listed in this FDA 510(k) record. The listed applicant is Robert I. Chien & Assoc., Inc.. It received FDA 510(k) clearance on 1981-07-20 under 510(k) number K811631. 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 (MADE IN CHINA)?

THERMOMETER (MADE IN CHINA) is a medical device that received FDA 510(k) clearance on 1981-07-20. The listed applicant is Robert I. Chien & Assoc., Inc.. The 510(k) number is K811631.

When did THERMOMETER (MADE IN CHINA) receive FDA 510(k) clearance?

THERMOMETER (MADE IN CHINA) received FDA 510(k) clearance on 1981-07-20, under 510(k) number K811631.

Who is the listed applicant for THERMOMETER (MADE IN CHINA)?

The FDA 510(k) record lists Robert I. Chien & Assoc., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THERMOMETER (MADE IN CHINA)?

The FDA product code for THERMOMETER (MADE IN CHINA) 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

Other records listing Robert I. Chien & Assoc., Inc. as applicant

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.

K822151SURGICAL INSTRUMENTS REPRESENT. 4 CLASSK811632UNSTERILIZED LAPAROTOMY SPONGES (CHINA)K810054RICA (DIAGNOSTIC INSTRUMENTS)K801819SURGICAL INSTRUMENTSK801028RICA OR SMIC SURGICAL INSTRUMENTS

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

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

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