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FDA 510(k)

BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F.

K-Number: K903567 · 1990-09-24

ApplicantOrganon Teknika Corp.
Decision Date1990-09-24
Product CodeFJI
Advisory CommitteeGU
DecisionSubstantially Equivalent

Device Summary

BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F. is the device name listed in this FDA 510(k) record. The listed applicant is Organon Teknika Corp.. It received FDA 510(k) clearance on 1990-09-24 under 510(k) number K903567. The device is classified under product code FJI. It was reviewed by the GU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F.?

BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F. is a medical device that received FDA 510(k) clearance on 1990-09-24. The listed applicant is Organon Teknika Corp.. The 510(k) number is K903567.

When did BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F. receive FDA 510(k) clearance?

BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F. received FDA 510(k) clearance on 1990-09-24, under 510(k) number K903567.

Who is the listed applicant for BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F.?

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

What is the FDA product code for BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F.?

The FDA product code for BIO* NEPHROSS ANDANTE, MODERATO, ALLEGIO H.F. is FJI.

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Other records listing Organon Teknika Corp. as applicant

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Related Devices (Code: FJI)

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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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