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FDA 510(k)

RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING

K-Number: K897137 · 1990-03-27

ApplicantResearch Medical, Inc.
Decision Date1990-03-27
Product CodeDTL
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING is the device name listed in this FDA 510(k) record. The listed applicant is Research Medical, Inc.. It received FDA 510(k) clearance on 1990-03-27 under 510(k) number K897137. The device is classified under product code DTL. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING?

RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING is a medical device that received FDA 510(k) clearance on 1990-03-27. The listed applicant is Research Medical, Inc.. The 510(k) number is K897137.

When did RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING receive FDA 510(k) clearance?

RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING received FDA 510(k) clearance on 1990-03-27, under 510(k) number K897137.

Who is the listed applicant for RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING?

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

What is the FDA product code for RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING?

The FDA product code for RMI AORTIC ROOT/CORONARY SINUS PRESSURE MONITORING is DTL.

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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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