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FDA 510(k)

HL-300 RECEIVER MODULE

K-Number: K915879 · 1992-01-27

ApplicantFukuda Denshi USA, Inc.
Decision Date1992-01-27
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

HL-300 RECEIVER MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Fukuda Denshi USA, Inc.. It received FDA 510(k) clearance on 1992-01-27 under 510(k) number K915879. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HL-300 RECEIVER MODULE?

HL-300 RECEIVER MODULE is a medical device that received FDA 510(k) clearance on 1992-01-27. The listed applicant is Fukuda Denshi USA, Inc.. The 510(k) number is K915879.

When did HL-300 RECEIVER MODULE receive FDA 510(k) clearance?

HL-300 RECEIVER MODULE received FDA 510(k) clearance on 1992-01-27, under 510(k) number K915879.

Who is the listed applicant for HL-300 RECEIVER MODULE?

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

What is the FDA product code for HL-300 RECEIVER MODULE?

The FDA product code for HL-300 RECEIVER MODULE is DPS.

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Related Devices (Code: DPS)

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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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