FDA 510(k)

BIVONA CUFF MAINTENANCE DEVICE (CMD)

K-Number: K914183 · 1991-10-23

Decision Date1991-10-23

Product CodeJOH

Advisory CommitteeAN

DecisionSubstantially Equivalent

Device Summary

BIVONA CUFF MAINTENANCE DEVICE (CMD) 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 1991-10-23 under 510(k) number K914183. The device is classified under product code JOH. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BIVONA CUFF MAINTENANCE DEVICE (CMD)?

BIVONA CUFF MAINTENANCE DEVICE (CMD) is a medical device that received FDA 510(k) clearance on 1991-10-23. The listed applicant is Bivona Medical Technologies. The 510(k) number is K914183.

When did BIVONA CUFF MAINTENANCE DEVICE (CMD) receive FDA 510(k) clearance?

BIVONA CUFF MAINTENANCE DEVICE (CMD) received FDA 510(k) clearance on 1991-10-23, under 510(k) number K914183.

Who is the listed applicant for BIVONA CUFF MAINTENANCE DEVICE (CMD)?

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 CUFF MAINTENANCE DEVICE (CMD)?

The FDA product code for BIVONA CUFF MAINTENANCE DEVICE (CMD) is JOH.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.