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FDA 510(k)

MODEL 535-03 TRACE A PACE

K-Number: K812755 · 1981-11-16

ApplicantIntermedics, Inc.
Decision Date1981-11-16
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL 535-03 TRACE A PACE is the device name listed in this FDA 510(k) record. The listed applicant is Intermedics, Inc.. It received FDA 510(k) clearance on 1981-11-16 under 510(k) number K812755. 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 MODEL 535-03 TRACE A PACE?

MODEL 535-03 TRACE A PACE is a medical device that received FDA 510(k) clearance on 1981-11-16. The listed applicant is Intermedics, Inc.. The 510(k) number is K812755.

When did MODEL 535-03 TRACE A PACE receive FDA 510(k) clearance?

MODEL 535-03 TRACE A PACE received FDA 510(k) clearance on 1981-11-16, under 510(k) number K812755.

Who is the listed applicant for MODEL 535-03 TRACE A PACE?

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

What is the FDA product code for MODEL 535-03 TRACE A PACE?

The FDA product code for MODEL 535-03 TRACE A PACE is DXH. This falls under the Hematology category.

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Other records listing Intermedics, Inc. as applicant

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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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