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FDA 510(k)

SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION

K-Number: K911761 · 1991-10-31

ApplicantS & W Medico Teknik
Decision Date1991-10-31
Product CodeDQA
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION 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 1991-10-31 under 510(k) number K911761. 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 SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION?

SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-10-31. The listed applicant is S & W Medico Teknik. The 510(k) number is K911761.

When did SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION receive FDA 510(k) clearance?

SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION received FDA 510(k) clearance on 1991-10-31, under 510(k) number K911761.

Who is the listed applicant for SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION?

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 SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION?

The FDA product code for SYSTEM ATHENA, TYPE 9266 SA02, MODIFICATION 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.

K9409339267 SPO2 ATHENA MODULEK913013TCPO2 9260 MODULE - SYSTEM ATHENAK915633MOD. TYPE 9230 TEMP 1 AND TEMP 2 SYSTEM ATHENAK9301349055 IRCA OPTION FOR SYSTEM ATHENA 9050 NTK9234189293/1 INTERFACE MODULEK911611SYSTEM ATHENA, MODIFICATION

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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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