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FDA 510(k)

ACCU-CHEK TRANS-TELEPHONIC PACEMAKER TR

K-Number: K811758 · 1981-08-03

ApplicantPowers Medical Systmes
Decision Date1981-08-03
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ACCU-CHEK TRANS-TELEPHONIC PACEMAKER TR is the device name listed in this FDA 510(k) record. The listed applicant is Powers Medical Systmes. It received FDA 510(k) clearance on 1981-08-03 under 510(k) number K811758. 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 ACCU-CHEK TRANS-TELEPHONIC PACEMAKER TR?

ACCU-CHEK TRANS-TELEPHONIC PACEMAKER TR is a medical device that received FDA 510(k) clearance on 1981-08-03. The listed applicant is Powers Medical Systmes. The 510(k) number is K811758.

When did ACCU-CHEK TRANS-TELEPHONIC PACEMAKER TR receive FDA 510(k) clearance?

ACCU-CHEK TRANS-TELEPHONIC PACEMAKER TR received FDA 510(k) clearance on 1981-08-03, under 510(k) number K811758.

Who is the listed applicant for ACCU-CHEK TRANS-TELEPHONIC PACEMAKER TR?

The FDA 510(k) record lists Powers Medical Systmes as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for ACCU-CHEK TRANS-TELEPHONIC PACEMAKER TR?

The FDA product code for ACCU-CHEK TRANS-TELEPHONIC PACEMAKER TR is DXH. This falls under the Hematology category.

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Other records listing Powers Medical Systmes 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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