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FDA 510(k)

MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC

K-Number: K870839 · 1987-05-22

ApplicantDirected Energy, Inc.
Decision Date1987-05-22
Product CodeHQF
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC is the device name listed in this FDA 510(k) record. The listed applicant is Directed Energy, Inc.. It received FDA 510(k) clearance on 1987-05-22 under 510(k) number K870839. The device is classified under product code HQF. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC?

MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC is a medical device that received FDA 510(k) clearance on 1987-05-22. The listed applicant is Directed Energy, Inc.. The 510(k) number is K870839.

When did MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC receive FDA 510(k) clearance?

MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC received FDA 510(k) clearance on 1987-05-22, under 510(k) number K870839.

Who is the listed applicant for MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC?

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

What is the FDA product code for MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC?

The FDA product code for MODEL 10-C W/FL-10A/U OPTICAL ATTACHMENT/OPTHALMIC is HQF.

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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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