DIAMOND-5A/6A/8A
K-Number: K202156 · 2020-09-10
ApplicantDRGEM Corporation
Decision Date2020-09-10
Product CodeKPR
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
DIAMOND-5A/6A/8A is a medical device manufactured by DRGEM Corporation. It received FDA 510(k) clearance on 2020-09-10 under approval number K202156. The device is classified under product code KPR. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the DIAMOND-5A/6A/8A?
DIAMOND-5A/6A/8A is a medical device that received FDA 510(k) clearance on 2020-09-10. It is manufactured by DRGEM Corporation. The 510(k) number is K202156.
When was DIAMOND-5A/6A/8A approved by the FDA?
DIAMOND-5A/6A/8A received FDA 510(k) clearance on 2020-09-10, under approval number K202156.
What company makes DIAMOND-5A/6A/8A?
DIAMOND-5A/6A/8A is manufactured by DRGEM Corporation.
What is the FDA product code for DIAMOND-5A/6A/8A?
The FDA product code for DIAMOND-5A/6A/8A is KPR.
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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.