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FDA 510(k)

SYSTEM ATHENA, MODIFICATION

K-Number: K911611 · 1993-02-05

ApplicantS & W Medico Teknik
Decision Date1993-02-05
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SYSTEM ATHENA, 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 1993-02-05 under 510(k) number K911611. The device is classified under product code DRT. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEM ATHENA, MODIFICATION?

SYSTEM ATHENA, MODIFICATION is a medical device that received FDA 510(k) clearance on 1993-02-05. The listed applicant is S & W Medico Teknik. The 510(k) number is K911611.

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

SYSTEM ATHENA, MODIFICATION received FDA 510(k) clearance on 1993-02-05, under 510(k) number K911611.

Who is the listed applicant for SYSTEM ATHENA, 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, MODIFICATION?

The FDA product code for SYSTEM ATHENA, MODIFICATION is DRT.

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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 MODULEK922314VENTILATOR INTERFACE 9291/4

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Related Devices (Code: DRT)

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.

K254058DistaSense(TM) (v1)Life Detection TechnologiesK261286The Circadia C300 System (C300)Circadia Health, Inc.K252676The Circadia C300 System (C300)Circadia Health, Inc.K253388Sleepiz One+ (Model 2.5)Sleepiz AGK251364Sleepiz One+ (2.5)Sleepiz AGK234003The Circadia C200 SystemCircadia Technologies, 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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