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FDA 510(k)

FISONEB(R) II

K-Number: K950206 · 1995-01-27

ApplicantFisons Corp.
Decision Date1995-01-27
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

FISONEB(R) II is the device name listed in this FDA 510(k) record. The listed applicant is Fisons Corp.. It received FDA 510(k) clearance on 1995-01-27 under 510(k) number K950206. The device is classified under product code CAF. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the FISONEB(R) II?

FISONEB(R) II is a medical device that received FDA 510(k) clearance on 1995-01-27. The listed applicant is Fisons Corp.. The 510(k) number is K950206.

When did FISONEB(R) II receive FDA 510(k) clearance?

FISONEB(R) II received FDA 510(k) clearance on 1995-01-27, under 510(k) number K950206.

Who is the listed applicant for FISONEB(R) II?

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

What is the FDA product code for FISONEB(R) II?

The FDA product code for FISONEB(R) II is CAF.

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Other records listing Fisons 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.

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Related Devices (Code: CAF)

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

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