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FDA 510(k)

MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA

K-Number: K915633 · 1993-06-29

ApplicantS & W Medico Teknik
Decision Date1993-06-29
Product CodeFLL
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA is the device name listed in this FDA 510(k) record. The listed applicant is S & W Medico Teknik. It received FDA 510(k) clearance on 1993-06-29 under 510(k) number K915633. 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 MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA?

MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA is a medical device that received FDA 510(k) clearance on 1993-06-29. The listed applicant is S & W Medico Teknik. The 510(k) number is K915633.

When did MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA receive FDA 510(k) clearance?

MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA received FDA 510(k) clearance on 1993-06-29, under 510(k) number K915633.

Who is the listed applicant for MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA?

The FDA 510(k) record lists S & W Medico Teknik as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA?

The FDA product code for MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENA is FLL.

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Other records listing S & W Medico Teknik 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.

K9409339267 SPO2 ATHENA MODULEK913013TCPO2 9260 MODULE - SYSTEM ATHENAK9301349055 IRCA OPTION FOR SYSTEM ATHENA 9050 NTK9234189293/1 INTERFACE MODULEK911611SYSTEM ATHENA, MODIFICATIONK922314VENTILATOR INTERFACE 9291/4

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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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