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FDA 510(k)

ROMEO(TM) MODEL 1000

K-Number: K872889 · 1988-04-13

ApplicantDiva Medical Systems, Inc.
Decision Date1988-04-13
Product CodeCGA
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

ROMEO(TM) MODEL 1000 is the device name listed in this FDA 510(k) record. The listed applicant is Diva Medical Systems, Inc.. It received FDA 510(k) clearance on 1988-04-13 under 510(k) number K872889. The device is classified under product code CGA. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ROMEO(TM) MODEL 1000?

ROMEO(TM) MODEL 1000 is a medical device that received FDA 510(k) clearance on 1988-04-13. The listed applicant is Diva Medical Systems, Inc.. The 510(k) number is K872889.

When did ROMEO(TM) MODEL 1000 receive FDA 510(k) clearance?

ROMEO(TM) MODEL 1000 received FDA 510(k) clearance on 1988-04-13, under 510(k) number K872889.

Who is the listed applicant for ROMEO(TM) MODEL 1000?

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

What is the FDA product code for ROMEO(TM) MODEL 1000?

The FDA product code for ROMEO(TM) MODEL 1000 is CGA.

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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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