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FDA 510(k)

MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT

K-Number: K871218 · 1987-04-30

Decision Date1987-04-30
Product CodeFKP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT is the device name listed in this FDA 510(k) record. The listed applicant is Hospal Medical Corp.. It received FDA 510(k) clearance on 1987-04-30 under 510(k) number K871218. The device is classified under product code FKP. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT?

MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT is a medical device that received FDA 510(k) clearance on 1987-04-30. The listed applicant is Hospal Medical Corp.. The 510(k) number is K871218.

When did MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT receive FDA 510(k) clearance?

MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT received FDA 510(k) clearance on 1987-04-30, under 510(k) number K871218.

Who is the listed applicant for MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT?

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

What is the FDA product code for MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT?

The FDA product code for MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT is FKP.

Related Clinical Trials

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.

Other records listing Hospal Medical Corp. 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.

View all 55 devices →

Related Devices (Code: FKP)

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.

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.

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