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FDA 510(k)

BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device

K-Number: K191580 · 2019-07-08

Decision Date2019-07-08
Product CodeJAQ
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device is the device name listed in this FDA 510(k) record. The listed applicant is Varian Medical Systems, Inc.. It received FDA 510(k) clearance on 2019-07-08 under 510(k) number K191580. The device is classified under product code JAQ. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device?

BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device is a medical device that received FDA 510(k) clearance on 2019-07-08. The listed applicant is Varian Medical Systems, Inc.. The 510(k) number is K191580.

When did BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device receive FDA 510(k) clearance?

BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device received FDA 510(k) clearance on 2019-07-08, under 510(k) number K191580.

Who is the listed applicant for BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device?

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

What is the FDA product code for BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device?

The FDA product code for BRAVOS Afterloader System, Transfer Guide Tubes, Length Assessment Device is JAQ.

Other records listing Varian Medical Systems, Inc. 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: JAQ)

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.

Official Source

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