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FDA 510(k)

MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION

K-Number: K991786 · 1999-11-18

ApplicantGeneral Electric Medical Systems Information Techn
Decision Date1999-11-18
Product CodeDPS
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION is the device name listed in this FDA 510(k) record. The listed applicant is General Electric Medical Systems Information Techn. It received FDA 510(k) clearance on 1999-11-18 under 510(k) number K991786. The device is classified under product code DPS. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION?

MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION is a medical device that received FDA 510(k) clearance on 1999-11-18. The listed applicant is General Electric Medical Systems Information Techn. The 510(k) number is K991786.

When did MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION receive FDA 510(k) clearance?

MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION received FDA 510(k) clearance on 1999-11-18, under 510(k) number K991786.

Who is the listed applicant for MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION?

The FDA 510(k) record lists General Electric Medical Systems Information Techn as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION?

The FDA product code for MARS UNITY WORKSTATION WITH HEART RATE VARIABILITY (HRV) OPTION is DPS.

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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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