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FDA 510(k)

AMBULATORY MONITORING DEVICE

K-Number: K833162 · 1984-01-10

ApplicantOxford Medilog, Inc.
Decision Date1984-01-10
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

AMBULATORY MONITORING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Oxford Medilog, Inc.. It received FDA 510(k) clearance on 1984-01-10 under 510(k) number K833162. 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 AMBULATORY MONITORING DEVICE?

AMBULATORY MONITORING DEVICE is a medical device that received FDA 510(k) clearance on 1984-01-10. The listed applicant is Oxford Medilog, Inc.. The 510(k) number is K833162.

When did AMBULATORY MONITORING DEVICE receive FDA 510(k) clearance?

AMBULATORY MONITORING DEVICE received FDA 510(k) clearance on 1984-01-10, under 510(k) number K833162.

Who is the listed applicant for AMBULATORY MONITORING DEVICE?

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

What is the FDA product code for AMBULATORY MONITORING DEVICE?

The FDA product code for AMBULATORY MONITORING DEVICE is DSI.

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Other records listing Oxford Medilog, Inc. as applicant

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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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