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FDA 510(k)

9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT

K-Number: K930134 · 1993-04-09

ApplicantS & W Medico Teknik
Decision Date1993-04-09
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT 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 1993-04-09 under 510(k) number K930134. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the 9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT?

9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT is a medical device that received FDA 510(k) clearance on 1993-04-09. The listed applicant is S & W Medico Teknik. The 510(k) number is K930134.

When did 9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT receive FDA 510(k) clearance?

9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT received FDA 510(k) clearance on 1993-04-09, under 510(k) number K930134.

Who is the listed applicant for 9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT?

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 9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT?

The FDA product code for 9055 IRCA OPTION FOR SYSTEM ATHENA 9050 NT is DPS.

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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 ATHENAK9234189293/1 INTERFACE MODULEK911611SYSTEM ATHENA, MODIFICATIONK922314VENTILATOR INTERFACE 9291/4

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Related Devices (Code: DPS)

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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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