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FDA 510(k)

COMPUTER

K-Number: K844665 · 1985-02-13

ApplicantBurdick Corp.
Decision Date1985-02-13
Product CodeDXG
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

COMPUTER is the device name listed in this FDA 510(k) record. The listed applicant is Burdick Corp.. It received FDA 510(k) clearance on 1985-02-13 under 510(k) number K844665. The device is classified under product code DXG. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the COMPUTER?

COMPUTER is a medical device that received FDA 510(k) clearance on 1985-02-13. The listed applicant is Burdick Corp.. The 510(k) number is K844665.

When did COMPUTER receive FDA 510(k) clearance?

COMPUTER received FDA 510(k) clearance on 1985-02-13, under 510(k) number K844665.

Who is the listed applicant for COMPUTER?

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

What is the FDA product code for COMPUTER?

The FDA product code for COMPUTER is DXG.

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Related PubMed Literature

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.

PMID: 37288633[Roadmap of Medical Device for Implanted Brain-computer Interface].Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation ()PMID: 31625336[Researching on the Classification of Computer Aided Diagnosis/Detection Software].Zhongguo yi liao qi xie za zhi = Chinese journal of medical instrumentation ()

Other records listing Burdick Corp. 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.

K942565ALTAIR-DISC RECORDERK941351BURDICK PRO2 OXIMETERK904032ELITE II ELECTROCARDIOGRAPHK903565E560 ELECTROCARDIOGRAPHK900729NEOSERV 824K885085ERGOMED 840/ERGOMED 840L

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Related Devices (Code: DXG)

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.

K253092Argos Infinity (Rev. 1.0)Retia Medical Systems, Inc.K251275VitalStream ART Connect; VitalStream-HemoCaretaker MedicalK232048Cogent™ Hemodynamic Monitoring System; Cogent™ HMSIcu MedicalK212529Hypotension Decision Assist Model HDA-OR2Directed Systems, Ltd.K192169PulsioFlex Monitoring System with ProAQT SensorPulsion Medical Systems SEK193179EV1000 Clinical PlatformEdwards Lifesciences, LLC

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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