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FDA 510(k)

CARD GUARD-3000 ECG TELEPHONE ADAPTER

K-Number: K910450 · 1991-05-07

ApplicantMedtech Industries, Inc.
Decision Date1991-05-07
Product CodeDXH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CARD GUARD-3000 ECG TELEPHONE ADAPTER is the device name listed in this FDA 510(k) record. The listed applicant is Medtech Industries, Inc.. It received FDA 510(k) clearance on 1991-05-07 under 510(k) number K910450. 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 CARD GUARD-3000 ECG TELEPHONE ADAPTER?

CARD GUARD-3000 ECG TELEPHONE ADAPTER is a medical device that received FDA 510(k) clearance on 1991-05-07. The listed applicant is Medtech Industries, Inc.. The 510(k) number is K910450.

When did CARD GUARD-3000 ECG TELEPHONE ADAPTER receive FDA 510(k) clearance?

CARD GUARD-3000 ECG TELEPHONE ADAPTER received FDA 510(k) clearance on 1991-05-07, under 510(k) number K910450.

Who is the listed applicant for CARD GUARD-3000 ECG TELEPHONE ADAPTER?

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

What is the FDA product code for CARD GUARD-3000 ECG TELEPHONE ADAPTER?

The FDA product code for CARD GUARD-3000 ECG TELEPHONE ADAPTER is DXH. This falls under the Hematology category.

Related Clinical Trials

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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Other records listing Medtech Industries, 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.

K910451CARD GUARD, MODEL CG-2000AK842819HOOK PUNCH FORCEPS FOR ARTHROSCOPYK842820ARTHROSCOPY KNIVES

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.

K250233PreemptiveAI Clinical SDKMeasure Labs, Inc. (Dba Preemptiveai, Inc.)K250258HeartBeam AIMIGo with 12-L ECG Synthesis Software SystemHeartbeam, Inc.K243438MEMO Patch M (MPT-E08R-UNC01)Huinno Co., Ltd.K243981Hexoskin Medical System (7100-00016)Carre Technologies, Inc.K243003VitalSigns 1-Lead Holter (VSH101)VitalSigns Technology Co., Ltd.K233521QT ECG (QTERD100)QT Medical, Inc.

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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