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FDA 510(k)

MBM(TM) MONITRAL (R) BICARBONATE MODULE

K-Number: K850179 · 1985-02-28

ApplicantHospal Medical Corp.
Decision Date1985-02-28
Product CodeFKP
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

MBM(TM) MONITRAL (R) BICARBONATE MODULE 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 1985-02-28 under 510(k) number K850179. 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 MBM(TM) MONITRAL (R) BICARBONATE MODULE?

MBM(TM) MONITRAL (R) BICARBONATE MODULE is a medical device that received FDA 510(k) clearance on 1985-02-28. The listed applicant is Hospal Medical Corp.. The 510(k) number is K850179.

When did MBM(TM) MONITRAL (R) BICARBONATE MODULE receive FDA 510(k) clearance?

MBM(TM) MONITRAL (R) BICARBONATE MODULE received FDA 510(k) clearance on 1985-02-28, under 510(k) number K850179.

Who is the listed applicant for MBM(TM) MONITRAL (R) BICARBONATE MODULE?

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 MBM(TM) MONITRAL (R) BICARBONATE MODULE?

The FDA product code for MBM(TM) MONITRAL (R) BICARBONATE MODULE is FKP.

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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.

K893742FILTRAL TM 20 HEMODIALYZER/FILTERK884365MULTIFLOW(TM) 60 KITK884326FILTRAL TM 8 HEMODIALYZERK883307CARDIOFLOW 100 HEMOCONCENTRATOR/PREPARATION KITK872767FILTRAL 10, FILTRAL 12, FILTRAL 16 HEMODIALYZERK871218MONITRAL S GS HEMODIALYSIS SINGLE PATIENT UNIT

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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.

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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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