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FDA 510(k)

CARDIOPHONICS 1000 MEMORY MONITOR

K-Number: K992772 · 1999-09-17

ApplicantRlt Medical Assoc., Inc.
Decision Date1999-09-17
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARDIOPHONICS 1000 MEMORY MONITOR is the device name listed in this FDA 510(k) record. The listed applicant is Rlt Medical Assoc., Inc.. It received FDA 510(k) clearance on 1999-09-17 under 510(k) number K992772. 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 CARDIOPHONICS 1000 MEMORY MONITOR?

CARDIOPHONICS 1000 MEMORY MONITOR is a medical device that received FDA 510(k) clearance on 1999-09-17. The listed applicant is Rlt Medical Assoc., Inc.. The 510(k) number is K992772.

When did CARDIOPHONICS 1000 MEMORY MONITOR receive FDA 510(k) clearance?

CARDIOPHONICS 1000 MEMORY MONITOR received FDA 510(k) clearance on 1999-09-17, under 510(k) number K992772.

Who is the listed applicant for CARDIOPHONICS 1000 MEMORY MONITOR?

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

What is the FDA product code for CARDIOPHONICS 1000 MEMORY MONITOR?

The FDA product code for CARDIOPHONICS 1000 MEMORY MONITOR is DXH. This falls under the Hematology category.

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Other records listing Rlt Medical Assoc., 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.

K934975TELEPHONE ELECTROCARDIOGRAPH TRANSMITTERK915224CARDIOPHONICS MEMORY TRANSMITTER

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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