EXPD 4343P, EXPD 3643P
K-Number: K193031 · 2019-11-22
ApplicantDRTECH Corporation
Decision Date2019-11-22
Product CodeMQB
Advisory CommitteeRA
DecisionSubstantially Equivalent
Device Summary
EXPD 4343P, EXPD 3643P is a medical device manufactured by DRTECH Corporation. It received FDA 510(k) clearance on 2019-11-22 under approval number K193031. The device is classified under product code MQB. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the EXPD 4343P, EXPD 3643P?
EXPD 4343P, EXPD 3643P is a medical device that received FDA 510(k) clearance on 2019-11-22. It is manufactured by DRTECH Corporation. The 510(k) number is K193031.
When was EXPD 4343P, EXPD 3643P approved by the FDA?
EXPD 4343P, EXPD 3643P received FDA 510(k) clearance on 2019-11-22, under approval number K193031.
What company makes EXPD 4343P, EXPD 3643P?
EXPD 4343P, EXPD 3643P is manufactured by DRTECH Corporation.
What is the FDA product code for EXPD 4343P, EXPD 3643P?
The FDA product code for EXPD 4343P, EXPD 3643P is MQB.
Other Devices by DRTECH Corporation
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K160143ClearVision ExamVue Flat Panel DetectorJpi Healthcare, Inc.
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.