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FDA 510(k)

SYSTEM ATHENA - PRODUCT ENHANCEMENTS

K-Number: K912049 · 1991-12-05

ApplicantS & W Medico Teknik
Decision Date1991-12-05
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SYSTEM ATHENA - PRODUCT ENHANCEMENTS 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 1991-12-05 under 510(k) number K912049. 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 - PRODUCT ENHANCEMENTS?

SYSTEM ATHENA - PRODUCT ENHANCEMENTS is a medical device that received FDA 510(k) clearance on 1991-12-05. The listed applicant is S & W Medico Teknik. The 510(k) number is K912049.

When did SYSTEM ATHENA - PRODUCT ENHANCEMENTS receive FDA 510(k) clearance?

SYSTEM ATHENA - PRODUCT ENHANCEMENTS received FDA 510(k) clearance on 1991-12-05, under 510(k) number K912049.

Who is the listed applicant for SYSTEM ATHENA - PRODUCT ENHANCEMENTS?

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 - PRODUCT ENHANCEMENTS?

The FDA product code for SYSTEM ATHENA - PRODUCT ENHANCEMENTS is DRT.

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Other records listing S & W Medico Teknik as applicant

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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: DRT)

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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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