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FDA 510(k)

MINI HEART

K-Number: K923690 · 1992-10-20

ApplicantB&B Medical Technologies, Inc.
Decision Date1992-10-20
Product CodeCAF
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

MINI HEART is the device name listed in this FDA 510(k) record. The listed applicant is B&B Medical Technologies, Inc.. It received FDA 510(k) clearance on 1992-10-20 under 510(k) number K923690. 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 MINI HEART?

MINI HEART is a medical device that received FDA 510(k) clearance on 1992-10-20. The listed applicant is B&B Medical Technologies, Inc.. The 510(k) number is K923690.

When did MINI HEART receive FDA 510(k) clearance?

MINI HEART received FDA 510(k) clearance on 1992-10-20, under 510(k) number K923690.

Who is the listed applicant for MINI HEART?

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

What is the FDA product code for MINI HEART?

The FDA product code for MINI HEART is CAF.

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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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