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FDA 510(k)

OM-1 DIAPHANOGRAPHY LIGHT TRANSILLUMINATION SYSTEM SOR MAMMOGRAPHY

K-Number: K837443 · 1983-06-10

ApplicantMedical Diagnostic Instruments, Inc.
Decision Date1983-06-10
Product Code
DecisionSubstantially Equivalent

Device Summary

OM-1 DIAPHANOGRAPHY LIGHT TRANSILLUMINATION SYSTEM SOR MAMMOGRAPHY is the device name listed in this FDA 510(k) record. The listed applicant is Medical Diagnostic Instruments, Inc.. It received FDA 510(k) clearance on 1983-06-10 under 510(k) number K837443. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the OM-1 DIAPHANOGRAPHY LIGHT TRANSILLUMINATION SYSTEM SOR MAMMOGRAPHY?

OM-1 DIAPHANOGRAPHY LIGHT TRANSILLUMINATION SYSTEM SOR MAMMOGRAPHY is a medical device that received FDA 510(k) clearance on 1983-06-10. The listed applicant is Medical Diagnostic Instruments, Inc.. The 510(k) number is K837443.

When did OM-1 DIAPHANOGRAPHY LIGHT TRANSILLUMINATION SYSTEM SOR MAMMOGRAPHY receive FDA 510(k) clearance?

OM-1 DIAPHANOGRAPHY LIGHT TRANSILLUMINATION SYSTEM SOR MAMMOGRAPHY received FDA 510(k) clearance on 1983-06-10, under 510(k) number K837443.

Who is the listed applicant for OM-1 DIAPHANOGRAPHY LIGHT TRANSILLUMINATION SYSTEM SOR MAMMOGRAPHY?

The FDA 510(k) record lists Medical Diagnostic Instruments, Inc. as the applicant. This does not by itself establish the device manufacturer.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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