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FDA 510(k)

THE VITA 2 DISPOSABLE DIALYZER

K-Number: K801634 · 1980-12-17

ApplicantBellco Artifidial Organ Spec., Inc.
Decision Date1980-12-17
Product CodeFHS
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

THE VITA 2 DISPOSABLE DIALYZER is the device name listed in this FDA 510(k) record. The listed applicant is Bellco Artifidial Organ Spec., Inc.. It received FDA 510(k) clearance on 1980-12-17 under 510(k) number K801634. The device is classified under product code FHS. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the THE VITA 2 DISPOSABLE DIALYZER?

THE VITA 2 DISPOSABLE DIALYZER is a medical device that received FDA 510(k) clearance on 1980-12-17. The listed applicant is Bellco Artifidial Organ Spec., Inc.. The 510(k) number is K801634.

When did THE VITA 2 DISPOSABLE DIALYZER receive FDA 510(k) clearance?

THE VITA 2 DISPOSABLE DIALYZER received FDA 510(k) clearance on 1980-12-17, under 510(k) number K801634.

Who is the listed applicant for THE VITA 2 DISPOSABLE DIALYZER?

The FDA 510(k) record lists Bellco Artifidial Organ Spec., Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for THE VITA 2 DISPOSABLE DIALYZER?

The FDA product code for THE VITA 2 DISPOSABLE DIALYZER is FHS.

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Other records listing Bellco Artifidial Organ Spec., 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.

K801633THE BRAVO NEW PARALLEL FLOW DIALYZERK801632THE BELLCO FISTULA NEEDLES

Related Devices (Code: FHS)

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.

K812811MICROCOIL 80 DIALYZERErika, Inc.K811974MICROCOIL 150 DIALYZERErika, Inc.K800723MICRO-COIL 100 COIL DIALYZERErika, Inc.K800174GAMBRO LUNDIA COIL DIALYZERGambro, Inc.K790223DIALYZER, CD-800 COILTravenol Laboratories, S.A.K781102DIALYZER, DISP., COIL, LUNDIAGambro, 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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