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FDA 510(k)

ECG MONITOR MODEL RM102

K-Number: K851496 · 1985-07-24

ApplicantHoneywell, Inc.
Decision Date1985-07-24
Product CodeDXJ
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

ECG MONITOR MODEL RM102 is the device name listed in this FDA 510(k) record. The listed applicant is Honeywell, Inc.. It received FDA 510(k) clearance on 1985-07-24 under 510(k) number K851496. The device is classified under product code DXJ. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ECG MONITOR MODEL RM102?

ECG MONITOR MODEL RM102 is a medical device that received FDA 510(k) clearance on 1985-07-24. The listed applicant is Honeywell, Inc.. The 510(k) number is K851496.

When did ECG MONITOR MODEL RM102 receive FDA 510(k) clearance?

ECG MONITOR MODEL RM102 received FDA 510(k) clearance on 1985-07-24, under 510(k) number K851496.

Who is the listed applicant for ECG MONITOR MODEL RM102?

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

What is the FDA product code for ECG MONITOR MODEL RM102?

The FDA product code for ECG MONITOR MODEL RM102 is DXJ.

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Other records listing Honeywell, Inc. as applicant

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Related Devices (Code: DXJ)

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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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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