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FDA 510(k)

9267 SPO2 ATHENA MODULE

K-Number: K940933 · 1995-11-29

ApplicantS & W Medico Teknik
Decision Date1995-11-29
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

9267 SPO2 ATHENA MODULE 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 1995-11-29 under 510(k) number K940933. The device is classified under product code DQA. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 9267 SPO2 ATHENA MODULE?

9267 SPO2 ATHENA MODULE is a medical device that received FDA 510(k) clearance on 1995-11-29. The listed applicant is S & W Medico Teknik. The 510(k) number is K940933.

When did 9267 SPO2 ATHENA MODULE receive FDA 510(k) clearance?

9267 SPO2 ATHENA MODULE received FDA 510(k) clearance on 1995-11-29, under 510(k) number K940933.

Who is the listed applicant for 9267 SPO2 ATHENA MODULE?

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 9267 SPO2 ATHENA MODULE?

The FDA product code for 9267 SPO2 ATHENA MODULE is DQA.

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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.

K913013TCPO2 9260 MODULE - SYSTEM ATHENAK915633MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENAK9301349055 IRCA OPTION FOR SYSTEM ATHENA 9050 NTK9234189293/1 INTERFACE MODULEK911611SYSTEM ATHENA, MODIFICATIONK922314VENTILATOR INTERFACE 9291/4

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Related Devices (Code: DQA)

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.

K252821Reusable Adult SpO2 Clip Sensor (3m) (M1196A); Reusable Adult SpO2 Clip Sensor (0.9m) (M1196T)Philips Medizin Systeme Böblingen GmbHK252655Pulse Oximeter (PO-A2AO, PO-A2AT, PO-A3AO, PO-H1AO, PO-B1AO, PO-C5AO, PO-C5AT, PO-C6AO, PO-C6AT)Shenzhen Imdk Medical Technology Co., Ltd.K253887Nasal Alar SpO2 Sensor (989803205381); Nasal Alar SpO2 Sensor (989803205391); Nasal Alar Sp02 Sensor (989803205401)Philips Medizin SystemeK260931Unimed Reusable Finger Clip SpO2 Sensors (U403-49R and U103-49R)Unimed Medical Supplies, Inc.K252448AViTA Pulse Oximeter (SP61)Avita CorporationK252805YUWELL® Finger Pulse Oximeter (YX105, YX106, YX110, YX310)Jiangsu Yuyue Medical Equipment & Supply 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.

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