FDA 510(k)

HMS-5000

K-Number: K914085 · 1991-11-19

Decision Date1991-11-19

Product CodeBZG

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

HMS-5000 is the device name listed in this FDA 510(k) record. The listed applicant is Vitalog Monitoring,Inc.. It received FDA 510(k) clearance on 1991-11-19 under 510(k) number K914085. The device is classified under product code BZG. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the HMS-5000?

HMS-5000 is a medical device that received FDA 510(k) clearance on 1991-11-19. The listed applicant is Vitalog Monitoring,Inc.. The 510(k) number is K914085.

When did HMS-5000 receive FDA 510(k) clearance?

HMS-5000 received FDA 510(k) clearance on 1991-11-19, under 510(k) number K914085.

Who is the listed applicant for HMS-5000?

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

What is the FDA product code for HMS-5000?

The FDA product code for HMS-5000 is BZG.

Other records listing Vitalog Monitoring,Inc. as applicant

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.

K935510VX4 RECORDING PULSE OXIMETER K914620HMS-4000 PHYSIOLOGICAL MONITOR, MODIFICATION K910950HMS-4000 MULTICHANNEL PHYSIO MONIT SYST, MODIFIED

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.