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FDA 510(k)

BIVONA CARDEN INTERMITTENT JETTING DEVICE

K-Number: K895946 · 1990-01-09

ApplicantBivona Medical Technologies
Decision Date1990-01-09
Product CodeBTL
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BIVONA CARDEN INTERMITTENT JETTING DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is Bivona Medical Technologies. It received FDA 510(k) clearance on 1990-01-09 under 510(k) number K895946. The device is classified under product code BTL. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIVONA CARDEN INTERMITTENT JETTING DEVICE?

BIVONA CARDEN INTERMITTENT JETTING DEVICE is a medical device that received FDA 510(k) clearance on 1990-01-09. The listed applicant is Bivona Medical Technologies. The 510(k) number is K895946.

When did BIVONA CARDEN INTERMITTENT JETTING DEVICE receive FDA 510(k) clearance?

BIVONA CARDEN INTERMITTENT JETTING DEVICE received FDA 510(k) clearance on 1990-01-09, under 510(k) number K895946.

Who is the listed applicant for BIVONA CARDEN INTERMITTENT JETTING DEVICE?

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

What is the FDA product code for BIVONA CARDEN INTERMITTENT JETTING DEVICE?

The FDA product code for BIVONA CARDEN INTERMITTENT JETTING DEVICE is BTL.

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Other records listing Bivona Medical Technologies as applicant

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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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