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FDA 510(k)

PECGASYS REMOTE TRANSMISSION UNIT

K-Number: K831092 · 1983-07-19

ApplicantDatamedix
Decision Date1983-07-19
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

PECGASYS REMOTE TRANSMISSION UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Datamedix. It received FDA 510(k) clearance on 1983-07-19 under 510(k) number K831092. 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 PECGASYS REMOTE TRANSMISSION UNIT?

PECGASYS REMOTE TRANSMISSION UNIT is a medical device that received FDA 510(k) clearance on 1983-07-19. The listed applicant is Datamedix. The 510(k) number is K831092.

When did PECGASYS REMOTE TRANSMISSION UNIT receive FDA 510(k) clearance?

PECGASYS REMOTE TRANSMISSION UNIT received FDA 510(k) clearance on 1983-07-19, under 510(k) number K831092.

Who is the listed applicant for PECGASYS REMOTE TRANSMISSION UNIT?

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

What is the FDA product code for PECGASYS REMOTE TRANSMISSION UNIT?

The FDA product code for PECGASYS REMOTE TRANSMISSION UNIT is DXH. This falls under the Hematology category.

Related Clinical Trials

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Other records listing Datamedix 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.

K810027DATAMEDIX PECGASYS SYSTEM

Related Devices (Code: DXH)

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

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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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