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FDA 510(k)

DOCTORS REVIEW SYSTEM

K-Number: K970402 · 1997-03-26

ApplicantDigisonics, Inc.
Decision Date1997-03-26
Product CodeLLZ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

DOCTORS REVIEW SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Digisonics, Inc.. It received FDA 510(k) clearance on 1997-03-26 under 510(k) number K970402. The device is classified under product code LLZ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the DOCTORS REVIEW SYSTEM?

DOCTORS REVIEW SYSTEM is a medical device that received FDA 510(k) clearance on 1997-03-26. The listed applicant is Digisonics, Inc.. The 510(k) number is K970402.

When did DOCTORS REVIEW SYSTEM receive FDA 510(k) clearance?

DOCTORS REVIEW SYSTEM received FDA 510(k) clearance on 1997-03-26, under 510(k) number K970402.

Who is the listed applicant for DOCTORS REVIEW SYSTEM?

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

What is the FDA product code for DOCTORS REVIEW SYSTEM?

The FDA product code for DOCTORS REVIEW SYSTEM is LLZ.

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Official Source

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