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FDA 510(k)

CUSTO PORT 24-H ECG AMBULATORY RECORDER

K-Number: K854115 · 1986-01-27

ApplicantVersacor, Inc.
Decision Date1986-01-27
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

CUSTO PORT 24-H ECG AMBULATORY RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Versacor, Inc.. It received FDA 510(k) clearance on 1986-01-27 under 510(k) number K854115. The device is classified under product code DSI. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the CUSTO PORT 24-H ECG AMBULATORY RECORDER?

CUSTO PORT 24-H ECG AMBULATORY RECORDER is a medical device that received FDA 510(k) clearance on 1986-01-27. The listed applicant is Versacor, Inc.. The 510(k) number is K854115.

When did CUSTO PORT 24-H ECG AMBULATORY RECORDER receive FDA 510(k) clearance?

CUSTO PORT 24-H ECG AMBULATORY RECORDER received FDA 510(k) clearance on 1986-01-27, under 510(k) number K854115.

Who is the listed applicant for CUSTO PORT 24-H ECG AMBULATORY RECORDER?

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

What is the FDA product code for CUSTO PORT 24-H ECG AMBULATORY RECORDER?

The FDA product code for CUSTO PORT 24-H ECG AMBULATORY RECORDER is DSI.

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Other records listing Versacor, 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.

K854745CUSTO VIT PULMONARY FUNCTION ANALYSIS SYSTEM

Related Devices (Code: DSI)

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.

K243349BodyGuardian Remote Monitoring System (BGRMS v3.0)Boston Scientific Cardiac Diagnostic Technologies, Inc.K250356MoMe ARC® Wireless Ambulatory ECG Monitoring and Detection System (32000)Infobionic, Inc.K240177Zio AT® device (A100A1001)iRhythm Technologies, Inc.K230265MoMe® ARC Wireless Ambulatory ECG Monitoring and Detection SystemInfobionic, Inc.K231276SmartCardia 7L PlatformSmartcardia SAK193104Unified Arrhythmia Diagnostic System PocketECG IVMedicalgorithmics S.A.

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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