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FDA 510(k)

ACCUCORE TELEMETRY, MODIFICATION

K-Number: K905506 · 1991-09-06

ApplicantS & W Medico Teknik
Decision Date1991-09-06
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACCUCORE TELEMETRY, 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 1991-09-06 under 510(k) number K905506. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ACCUCORE TELEMETRY, MODIFICATION?

ACCUCORE TELEMETRY, MODIFICATION is a medical device that received FDA 510(k) clearance on 1991-09-06. The listed applicant is S & W Medico Teknik. The 510(k) number is K905506.

When did ACCUCORE TELEMETRY, MODIFICATION receive FDA 510(k) clearance?

ACCUCORE TELEMETRY, MODIFICATION received FDA 510(k) clearance on 1991-09-06, under 510(k) number K905506.

Who is the listed applicant for ACCUCORE TELEMETRY, 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 ACCUCORE TELEMETRY, MODIFICATION?

The FDA product code for ACCUCORE TELEMETRY, MODIFICATION is DSI.

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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: DSI)

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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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