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FDA 510(k)

AMO DIPLOMAX/OPSYS CONSOLE

K-Number: K971186 · 1997-06-13

ApplicantAllergan, Inc.
Decision Date1997-06-13
Product CodeHQC
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

AMO DIPLOMAX/OPSYS CONSOLE is the device name listed in this FDA 510(k) record. The listed applicant is Allergan, Inc.. It received FDA 510(k) clearance on 1997-06-13 under 510(k) number K971186. The device is classified under product code HQC. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the AMO DIPLOMAX/OPSYS CONSOLE?

AMO DIPLOMAX/OPSYS CONSOLE is a medical device that received FDA 510(k) clearance on 1997-06-13. The listed applicant is Allergan, Inc.. The 510(k) number is K971186.

When did AMO DIPLOMAX/OPSYS CONSOLE receive FDA 510(k) clearance?

AMO DIPLOMAX/OPSYS CONSOLE received FDA 510(k) clearance on 1997-06-13, under 510(k) number K971186.

Who is the listed applicant for AMO DIPLOMAX/OPSYS CONSOLE?

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

What is the FDA product code for AMO DIPLOMAX/OPSYS CONSOLE?

The FDA product code for AMO DIPLOMAX/OPSYS CONSOLE is HQC.

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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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