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FDA 510(k)

MODEL 640 LINEAR SCANNER

K-Number: K827176 · 1982-12-14

ApplicantGe Medical Systems Information Technologies
Decision Date1982-12-14
Product Code
DecisionSubstantially Equivalent

Device Summary

MODEL 640 LINEAR SCANNER is the device name listed in this FDA 510(k) record. The listed applicant is Ge Medical Systems Information Technologies. It received FDA 510(k) clearance on 1982-12-14 under 510(k) number K827176. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 640 LINEAR SCANNER?

MODEL 640 LINEAR SCANNER is a medical device that received FDA 510(k) clearance on 1982-12-14. The listed applicant is Ge Medical Systems Information Technologies. The 510(k) number is K827176.

When did MODEL 640 LINEAR SCANNER receive FDA 510(k) clearance?

MODEL 640 LINEAR SCANNER received FDA 510(k) clearance on 1982-12-14, under 510(k) number K827176.

Who is the listed applicant for MODEL 640 LINEAR SCANNER?

The FDA 510(k) record lists Ge Medical Systems Information Technologies as the applicant. This does not by itself establish the device manufacturer.

Related Clinical Trials

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Other records listing Ge Medical Systems Information Technologies 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.

K120770QT GUARD PLUS ANALYSIS SYSTEMK102426CARESCAPE MODEL V100 VITAL SIGNS MONITORK09236912SL ECG ANALYSIS PROGRAMK093141MARS HOLTER ANALYSIS WORKSTATIONK092027CARESCAPE MONITOR B850K090702MODIFICATION TO DASH 2500 PATIENT MONITOR

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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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