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FDA 510(k)

PHONOTRACE 2000

K-Number: K820452 · 1982-04-16

ApplicantLowrance Electronics, Inc.
Decision Date1982-04-16
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PHONOTRACE 2000 is the device name listed in this FDA 510(k) record. The listed applicant is Lowrance Electronics, Inc.. It received FDA 510(k) clearance on 1982-04-16 under 510(k) number K820452. The device is classified under product code DXH. It was reviewed by the CV advisory panel. Product code DXH falls under the category of Hematology, which includes devices for blood cell counting, coagulation testing, and hemoglobin analysis. Devices in this category are subject to specific FDA regulatory requirements. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PHONOTRACE 2000?

PHONOTRACE 2000 is a medical device that received FDA 510(k) clearance on 1982-04-16. The listed applicant is Lowrance Electronics, Inc.. The 510(k) number is K820452.

When did PHONOTRACE 2000 receive FDA 510(k) clearance?

PHONOTRACE 2000 received FDA 510(k) clearance on 1982-04-16, under 510(k) number K820452.

Who is the listed applicant for PHONOTRACE 2000?

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

What is the FDA product code for PHONOTRACE 2000?

The FDA product code for PHONOTRACE 2000 is DXH. This falls under the Hematology category.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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