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FDA 510(k)

CALIBRATION KIT

K-Number: K911264 · 1991-08-02

ApplicantS & W Medico Teknik
Decision Date1991-08-02
Product CodeBXK
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

CALIBRATION KIT 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 1991-08-02 under 510(k) number K911264. The device is classified under product code BXK. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CALIBRATION KIT?

CALIBRATION KIT is a medical device that received FDA 510(k) clearance on 1991-08-02. The listed applicant is S & W Medico Teknik. The 510(k) number is K911264.

When did CALIBRATION KIT receive FDA 510(k) clearance?

CALIBRATION KIT received FDA 510(k) clearance on 1991-08-02, under 510(k) number K911264.

Who is the listed applicant for CALIBRATION KIT?

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 CALIBRATION KIT?

The FDA product code for CALIBRATION KIT is BXK.

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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: BXK)

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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