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FDA 510(k)

SONICAID MODEL MR-63 AMBULATORY ECG RECORDER

K-Number: K943862 · 1995-06-07

ApplicantOxford Instruments Medical Systems
Decision Date1995-06-07
Product CodeDSH
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

SONICAID MODEL MR-63 AMBULATORY ECG RECORDER is the device name listed in this FDA 510(k) record. The listed applicant is Oxford Instruments Medical Systems. It received FDA 510(k) clearance on 1995-06-07 under 510(k) number K943862. The device is classified under product code DSH. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SONICAID MODEL MR-63 AMBULATORY ECG RECORDER?

SONICAID MODEL MR-63 AMBULATORY ECG RECORDER is a medical device that received FDA 510(k) clearance on 1995-06-07. The listed applicant is Oxford Instruments Medical Systems. The 510(k) number is K943862.

When did SONICAID MODEL MR-63 AMBULATORY ECG RECORDER receive FDA 510(k) clearance?

SONICAID MODEL MR-63 AMBULATORY ECG RECORDER received FDA 510(k) clearance on 1995-06-07, under 510(k) number K943862.

Who is the listed applicant for SONICAID MODEL MR-63 AMBULATORY ECG RECORDER?

The FDA 510(k) record lists Oxford Instruments Medical Systems as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for SONICAID MODEL MR-63 AMBULATORY ECG RECORDER?

The FDA product code for SONICAID MODEL MR-63 AMBULATORY ECG RECORDER is DSH.

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Other records listing Oxford Instruments Medical Systems 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.

K992607SONICAID SYSTEM 8002K984052SYNERGY IOM SYSTEMK970902MEDILOG FD4K961638MEDILOG MPA-S

Related Devices (Code: DSH)

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.

K260157LifeLens Physiological MonitorLifeLens Technologies, Inc.K252389Rhythm Master ECG Patch (HM-15BB-AX, HM-15BW-AX, HM-15BW-DX)Smwmed, Inc.K253293VitaloJAK Clinic (Model 7100)Vitalograph , Ltd.K243650Zio® monitor (DFG0001)iRhythm Technologies, Inc.K243603AeviceMDAevice Health Pte. , Ltd.K242583AT-Patch (ATP-C130/ATP-C70)Atsens Co., Ltd.

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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