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FDA 510(k)

MAXICAMERA 400ZS

K-Number: K828544 · 1982-12-20

ApplicantGeneral Electric Co.
Decision Date1982-12-20
Product Code
DecisionSubstantially Equivalent

Device Summary

MAXICAMERA 400ZS is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Co.. It received FDA 510(k) clearance on 1982-12-20 under 510(k) number K828544. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MAXICAMERA 400ZS?

MAXICAMERA 400ZS is a medical device that received FDA 510(k) clearance on 1982-12-20. The listed applicant is General Electric Co.. The 510(k) number is K828544.

When did MAXICAMERA 400ZS receive FDA 510(k) clearance?

MAXICAMERA 400ZS received FDA 510(k) clearance on 1982-12-20, under 510(k) number K828544.

Who is the listed applicant for MAXICAMERA 400ZS?

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

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Other records listing General Electric Co. 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.

K103489GE VEO RECONSTRUCTION OPTIONK082317GE LUNAR FRAX 10-YEAR FRACTURE RISK SOFTWARE OPTIONK081921GE VIVID E9 ULTRASOUNDK073297GE LOGIQ P6K072952GE ECHOPACK072797GE LOGIQ I COMAPACT ULTRASOUND, GE LOGIQ E COMPACT ULTRASOUND, GE VIVID E COMPACT ULTRASOUND

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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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