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FDA 510(k)

TYPE 9210 ECG SYSTEM ATHENA

K-Number: K884117 · 1989-04-26

ApplicantS & W Medico Teknik
Decision Date1989-04-26
Product CodeDRT
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

TYPE 9210 ECG SYSTEM ATHENA 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 1989-04-26 under 510(k) number K884117. 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 TYPE 9210 ECG SYSTEM ATHENA?

TYPE 9210 ECG SYSTEM ATHENA is a medical device that received FDA 510(k) clearance on 1989-04-26. The listed applicant is S & W Medico Teknik. The 510(k) number is K884117.

When did TYPE 9210 ECG SYSTEM ATHENA receive FDA 510(k) clearance?

TYPE 9210 ECG SYSTEM ATHENA received FDA 510(k) clearance on 1989-04-26, under 510(k) number K884117.

Who is the listed applicant for TYPE 9210 ECG SYSTEM ATHENA?

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 TYPE 9210 ECG SYSTEM ATHENA?

The FDA product code for TYPE 9210 ECG SYSTEM ATHENA 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 MODULEK911611SYSTEM ATHENA, MODIFICATION

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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.

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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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