B R A H M S PCT sensitive KRYPTOR
K-Number: K171338 · 2017-05-31
ApplicantBrahms GmbH
Decision Date2017-05-31
Product CodePRI
Advisory CommitteeMI
DecisionSubstantially Equivalent
Device Summary
B R A H M S PCT sensitive KRYPTOR is a medical device manufactured by Brahms GmbH. It received FDA 510(k) clearance on 2017-05-31 under approval number K171338. The device is classified under product code PRI. It was reviewed by the MI advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the B R A H M S PCT sensitive KRYPTOR?
B R A H M S PCT sensitive KRYPTOR is a medical device that received FDA 510(k) clearance on 2017-05-31. It is manufactured by Brahms GmbH. The 510(k) number is K171338.
When was B R A H M S PCT sensitive KRYPTOR approved by the FDA?
B R A H M S PCT sensitive KRYPTOR received FDA 510(k) clearance on 2017-05-31, under approval number K171338.
What company makes B R A H M S PCT sensitive KRYPTOR?
B R A H M S PCT sensitive KRYPTOR is manufactured by Brahms GmbH.
What is the FDA product code for B R A H M S PCT sensitive KRYPTOR?
The FDA product code for B R A H M S PCT sensitive KRYPTOR is PRI.
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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.