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FDA 510(k)

SIEMENS SIRECUST PENTA SYSTEM AND ACCESSORIES

K-Number: K920445 · 1993-03-02

ApplicantSiemens Medical Electronics
Decision Date1993-03-02
Product CodeMHX
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SIEMENS SIRECUST PENTA SYSTEM AND ACCESSORIES is the device name listed in this FDA 510(k) record. The listed applicant is Siemens Medical Electronics. It received FDA 510(k) clearance on 1993-03-02 under 510(k) number K920445. The device is classified under product code MHX. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SIEMENS SIRECUST PENTA SYSTEM AND ACCESSORIES?

SIEMENS SIRECUST PENTA SYSTEM AND ACCESSORIES is a medical device that received FDA 510(k) clearance on 1993-03-02. The listed applicant is Siemens Medical Electronics. The 510(k) number is K920445.

When did SIEMENS SIRECUST PENTA SYSTEM AND ACCESSORIES receive FDA 510(k) clearance?

SIEMENS SIRECUST PENTA SYSTEM AND ACCESSORIES received FDA 510(k) clearance on 1993-03-02, under 510(k) number K920445.

Who is the listed applicant for SIEMENS SIRECUST PENTA SYSTEM AND ACCESSORIES?

The FDA 510(k) record lists Siemens Medical Electronics as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SIEMENS SIRECUST PENTA SYSTEM AND ACCESSORIES?

The FDA product code for SIEMENS SIRECUST PENTA SYSTEM AND ACCESSORIES is MHX.

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Other records listing Siemens Medical Electronics 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.

K935043SIEMENS CLINICAL WORK STATIONK921930SIEMENS SIRECUST 700 BEDSIDES/ACCESSORIES, MODIFIK914765SIEMENS NP NONINVASIVE BLOOD PRESS MEASUREMENT SYSK912070SIEMENS RADIOTOM 904 & 904E ELECTROSURGERY UNITK913489SIEMENS MICRO2 PULSE OXIMETERK905775SIEMENS ETCO2 CARTRIDGE

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Related Devices (Code: MHX)

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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