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FDA 510(k)

R-1000 ECG RECEIVER

K-Number: K851123 · 1985-05-15

ApplicantBrentwood Instruments, Inc.
Decision Date1985-05-15
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

R-1000 ECG RECEIVER is the device name listed in this FDA 510(k) record. The listed applicant is Brentwood Instruments, Inc.. It received FDA 510(k) clearance on 1985-05-15 under 510(k) number K851123. 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 R-1000 ECG RECEIVER?

R-1000 ECG RECEIVER is a medical device that received FDA 510(k) clearance on 1985-05-15. The listed applicant is Brentwood Instruments, Inc.. The 510(k) number is K851123.

When did R-1000 ECG RECEIVER receive FDA 510(k) clearance?

R-1000 ECG RECEIVER received FDA 510(k) clearance on 1985-05-15, under 510(k) number K851123.

Who is the listed applicant for R-1000 ECG RECEIVER?

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

What is the FDA product code for R-1000 ECG RECEIVER?

The FDA product code for R-1000 ECG RECEIVER is DXH. This falls under the Hematology category.

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Other records listing Brentwood Instruments, Inc. as applicant

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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

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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