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FDA 510(k)

FORTEC MI-100, BLOOD PRESSURE METER

K-Number: K862200 · 1986-11-18

ApplicantFortec Electronic Corp./Nam Tai
Decision Date1986-11-18
Product CodeDSK
Advisory CommitteeCV
DecisionSubstantially Equivalent

Device Summary

FORTEC MI-100, BLOOD PRESSURE METER is the device name listed in this FDA 510(k) record. The listed applicant is Fortec Electronic Corp./Nam Tai. It received FDA 510(k) clearance on 1986-11-18 under 510(k) number K862200. The device is classified under product code DSK. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FORTEC MI-100, BLOOD PRESSURE METER?

FORTEC MI-100, BLOOD PRESSURE METER is a medical device that received FDA 510(k) clearance on 1986-11-18. The listed applicant is Fortec Electronic Corp./Nam Tai. The 510(k) number is K862200.

When did FORTEC MI-100, BLOOD PRESSURE METER receive FDA 510(k) clearance?

FORTEC MI-100, BLOOD PRESSURE METER received FDA 510(k) clearance on 1986-11-18, under 510(k) number K862200.

Who is the listed applicant for FORTEC MI-100, BLOOD PRESSURE METER?

The FDA 510(k) record lists Fortec Electronic Corp./Nam Tai as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for FORTEC MI-100, BLOOD PRESSURE METER?

The FDA product code for FORTEC MI-100, BLOOD PRESSURE METER is DSK.

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Related Devices (Code: DSK)

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.

K231586Endophys Blood Pressure Monitor model BPM-30Endophys Technologies, LLCK160945Endophys Blood Pressure MonitorEndophys Holdings, LLCK080670MODIFICATION TO SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAtcor MedicalK070795SPHYGMOCOR CARDIOVASCULAR MANAGEMENT SYSTEMAtcor Medical Pty, Ltd.K033738MONITORING SYSTEM, MODEL ARGUS PB-2200Schiller AGK021517ABP FOR WINDOWSRozinn Electronics, Inc.

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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