Background Pattern Classification [BPc(TM)]
K-Number: K152301 · 2016-06-03
Decision Date2016-06-03
Product CodeOMA
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
Background Pattern Classification [BPc(TM)] is a medical device manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). It received FDA 510(k) clearance on 2016-06-03 under approval number K152301. The device is classified under product code OMA. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the Background Pattern Classification [BPc(TM)]?
Background Pattern Classification [BPc(TM)] is a medical device that received FDA 510(k) clearance on 2016-06-03. It is manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek). The 510(k) number is K152301.
When was Background Pattern Classification [BPc(TM)] approved by the FDA?
Background Pattern Classification [BPc(TM)] received FDA 510(k) clearance on 2016-06-03, under approval number K152301.
What company makes Background Pattern Classification [BPc(TM)]?
Background Pattern Classification [BPc(TM)] is manufactured by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek).
What is the FDA product code for Background Pattern Classification [BPc(TM)]?
The FDA product code for Background Pattern Classification [BPc(TM)] is OMA.
Related Clinical Trials
Other Devices by Natus Medical Incorporated Dba Excel-Tech Ltd. (Xltek)
Related Devices (Code: OMA)
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.