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FDA 510(k)

NIBP 9225 COMBI

K-Number: K912815 · 1992-10-09

ApplicantS & W Medico Teknik
Decision Date1992-10-09
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

NIBP 9225 COMBI 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 1992-10-09 under 510(k) number K912815. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the NIBP 9225 COMBI?

NIBP 9225 COMBI is a medical device that received FDA 510(k) clearance on 1992-10-09. The listed applicant is S & W Medico Teknik. The 510(k) number is K912815.

When did NIBP 9225 COMBI receive FDA 510(k) clearance?

NIBP 9225 COMBI received FDA 510(k) clearance on 1992-10-09, under 510(k) number K912815.

Who is the listed applicant for NIBP 9225 COMBI?

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 NIBP 9225 COMBI?

The FDA product code for NIBP 9225 COMBI is DXN.

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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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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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