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FDA 510(k)

BREAS, MODEL HA01

K-Number: K060790 · 2006-05-25

ApplicantBreas Medical AB
Decision Date2006-05-25
Product CodeBTT
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

BREAS, MODEL HA01 is the device name listed in this FDA 510(k) record. The listed applicant is Breas Medical AB. It received FDA 510(k) clearance on 2006-05-25 under 510(k) number K060790. The device is classified under product code BTT. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BREAS, MODEL HA01?

BREAS, MODEL HA01 is a medical device that received FDA 510(k) clearance on 2006-05-25. The listed applicant is Breas Medical AB. The 510(k) number is K060790.

When did BREAS, MODEL HA01 receive FDA 510(k) clearance?

BREAS, MODEL HA01 received FDA 510(k) clearance on 2006-05-25, under 510(k) number K060790.

Who is the listed applicant for BREAS, MODEL HA01?

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

What is the FDA product code for BREAS, MODEL HA01?

The FDA product code for BREAS, MODEL HA01 is BTT.

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Other records listing Breas Medical AB 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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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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