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FDA 510(k)

SYSTEM U3 FOR CIPROFLOXACIN

K-Number: K981639 · 1998-09-03

ApplicantAb Biodisk
Decision Date1998-09-03
Product CodeJWY
Advisory CommitteeMI
DecisionSubstantially Equivalent

Device Summary

SYSTEM U3 FOR CIPROFLOXACIN is the device name listed in this FDA 510(k) record. The listed applicant is Ab Biodisk. It received FDA 510(k) clearance on 1998-09-03 under 510(k) number K981639. The device is classified under product code JWY. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SYSTEM U3 FOR CIPROFLOXACIN?

SYSTEM U3 FOR CIPROFLOXACIN is a medical device that received FDA 510(k) clearance on 1998-09-03. The listed applicant is Ab Biodisk. The 510(k) number is K981639.

When did SYSTEM U3 FOR CIPROFLOXACIN receive FDA 510(k) clearance?

SYSTEM U3 FOR CIPROFLOXACIN received FDA 510(k) clearance on 1998-09-03, under 510(k) number K981639.

Who is the listed applicant for SYSTEM U3 FOR CIPROFLOXACIN?

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

What is the FDA product code for SYSTEM U3 FOR CIPROFLOXACIN?

The FDA product code for SYSTEM U3 FOR CIPROFLOXACIN is JWY.

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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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