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)

ZOMED PASSIVE TEMPERATURE PROBE

K-Number: K964286 · 1996-11-19

ApplicantZomed Intl.
Decision Date1996-11-19
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

ZOMED PASSIVE TEMPERATURE PROBE is the device name listed in this FDA 510(k) record. The listed applicant is Zomed Intl.. It received FDA 510(k) clearance on 1996-11-19 under 510(k) number K964286. The device is classified under product code FLL. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ZOMED PASSIVE TEMPERATURE PROBE?

ZOMED PASSIVE TEMPERATURE PROBE is a medical device that received FDA 510(k) clearance on 1996-11-19. The listed applicant is Zomed Intl.. The 510(k) number is K964286.

When did ZOMED PASSIVE TEMPERATURE PROBE receive FDA 510(k) clearance?

ZOMED PASSIVE TEMPERATURE PROBE received FDA 510(k) clearance on 1996-11-19, under 510(k) number K964286.

Who is the listed applicant for ZOMED PASSIVE TEMPERATURE PROBE?

The FDA 510(k) record lists Zomed Intl. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ZOMED PASSIVE TEMPERATURE PROBE?

The FDA product code for ZOMED PASSIVE TEMPERATURE PROBE is FLL.

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 Zomed Intl. 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.

K962692ZOMED MODEL 30-6 MULTIELECTRODE ARRAY PROBEK960695MODEL 200C ELECTROSURGICAL PROBEK960694ZOMED 30F ELECTROSURGICAL PROBEK954965ZOMED MODEL 20 & 30 ELECTROSURGICAL PROBESK952072ZOMED MODEL 500 ELECTROSURGICAL GENERATOR MODEL 200 ELECTROSURGICAL PROBEK951659ZOMED MODEL 10 CAUTERY BIOPSY DEVICE

View all 7 devices →

Related Devices (Code: FLL)

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.

K253162Temperature probes (T2252-PG); Temperature probes (TCMA-AG); Temperature probes (TCMA-PG); Temperature probes (TMQ-DAG); Temperature probes (THP-DAG)Unimed Medical Supplies, Inc.K251160Sterile temperature probe (Model: W0001ES, W0028ES, W0101FS-A, W0101FS-P, W0099LS, W0099FS, W0099PS)Shenzhen Med-Link Electronics Tech Co., Ltd.K250470Ear Thermometer (EAR-E101); Ear Thermometer (EAR-E102); Ear Thermometer (EAR-E103)Shenzhen AOJ Medical Technology Co., Ltd.K243000Reusable Temperature Probe (T1306, T2306, T3306, T4306); Disposable Temperature Probe (T5106, T6106)Shenzhen Medke Technology Co., Ltd.K250878YUWELL® Infrared Ear Thermometer (YHT100); YUWELL® Infrared Ear Thermometer (YHT107)Jiangsu Yuyue Medical Equipment & Supply Co., Ltd.K243082Infrared ThermometerGuangzhou Daxin Health Technology Co., 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.

↑