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FDA 510(k)

MODEL MR-45 AMBULATORY HOLTER MONITOR

K-Number: K872497 · 1987-10-06

ApplicantOxford Medilog, Inc.
Decision Date1987-10-06
Product CodeDSI
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MODEL MR-45 AMBULATORY HOLTER MONITOR 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 1987-10-06 under 510(k) number K872497. 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 MODEL MR-45 AMBULATORY HOLTER MONITOR?

MODEL MR-45 AMBULATORY HOLTER MONITOR is a medical device that received FDA 510(k) clearance on 1987-10-06. The listed applicant is Oxford Medilog, Inc.. The 510(k) number is K872497.

When did MODEL MR-45 AMBULATORY HOLTER MONITOR receive FDA 510(k) clearance?

MODEL MR-45 AMBULATORY HOLTER MONITOR received FDA 510(k) clearance on 1987-10-06, under 510(k) number K872497.

Who is the listed applicant for MODEL MR-45 AMBULATORY HOLTER MONITOR?

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 MODEL MR-45 AMBULATORY HOLTER MONITOR?

The FDA product code for MODEL MR-45 AMBULATORY HOLTER MONITOR is DSI.

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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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