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FDA 510(k)

EXACON TEMP. PROBES SYSTEM 8000-#TH-103

K-Number: K821556 · 1982-08-16

ApplicantSat Export Engineering & Trading
Decision Date1982-08-16
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

EXACON TEMP. PROBES SYSTEM 8000-#TH-103 is the device name listed in this FDA 510(k) record. The listed applicant is Sat Export Engineering & Trading. It received FDA 510(k) clearance on 1982-08-16 under 510(k) number K821556. 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 EXACON TEMP. PROBES SYSTEM 8000-#TH-103?

EXACON TEMP. PROBES SYSTEM 8000-#TH-103 is a medical device that received FDA 510(k) clearance on 1982-08-16. The listed applicant is Sat Export Engineering & Trading. The 510(k) number is K821556.

When did EXACON TEMP. PROBES SYSTEM 8000-#TH-103 receive FDA 510(k) clearance?

EXACON TEMP. PROBES SYSTEM 8000-#TH-103 received FDA 510(k) clearance on 1982-08-16, under 510(k) number K821556.

Who is the listed applicant for EXACON TEMP. PROBES SYSTEM 8000-#TH-103?

The FDA 510(k) record lists Sat Export Engineering & Trading as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for EXACON TEMP. PROBES SYSTEM 8000-#TH-103?

The FDA product code for EXACON TEMP. PROBES SYSTEM 8000-#TH-103 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.

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Other records listing Sat Export Engineering & Trading 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.

K821555EXACON THERMOMETER SYSTEM 8000K820153EXACON SCIENTIFIC INSTRUMENTS APS

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

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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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