DIAMOND-5A/6A/8A
K-Number: K192453 · 2019-10-01
ApplicantDRGEM Corporation
Decision Date2019-10-01
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 2019-10-01 under approval number K192453. 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 2019-10-01. It is manufactured by DRGEM Corporation. The 510(k) number is K192453.
When was DIAMOND-5A/6A/8A approved by the FDA?
DIAMOND-5A/6A/8A received FDA 510(k) clearance on 2019-10-01, under approval number K192453.
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.
Other Devices by DRGEM Corporation
Related Devices (Code: KPR)
K163203Carestream DRX-EvolutionCarestream Health, Inc.
K163115GC70Samsung Electronics Co., Ltd.
K152813FS-500DDR Medical Radiographic X-Ray SystemOrich Medical Equipment (Tianjin) Co., Ltd.
K162971Multix Fusion MaxSiemens Medical Solutions USA, Inc.
K161937CuattroDRCuattro, LLC
K162224ArtPix Mobile EZ2GOCmt Medical Technologies, Ltd.
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.