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FDA 510(k)

LED GOGGLES

K-Number: K831231 · 1983-05-16

ApplicantCadwell Laboratories, Inc.
Decision Date1983-05-16
Product CodeHLX
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

LED GOGGLES is the device name listed in this FDA 510(k) record. The listed applicant is Cadwell Laboratories, Inc.. It received FDA 510(k) clearance on 1983-05-16 under 510(k) number K831231. The device is classified under product code HLX. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LED GOGGLES?

LED GOGGLES is a medical device that received FDA 510(k) clearance on 1983-05-16. The listed applicant is Cadwell Laboratories, Inc.. The 510(k) number is K831231.

When did LED GOGGLES receive FDA 510(k) clearance?

LED GOGGLES received FDA 510(k) clearance on 1983-05-16, under 510(k) number K831231.

Who is the listed applicant for LED GOGGLES?

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

What is the FDA product code for LED GOGGLES?

The FDA product code for LED GOGGLES is HLX.

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Other records listing Cadwell Laboratories, Inc. as applicant

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Related Devices (Code: HLX)

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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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