Decision Date2005-09-14
Product CodeDXN
Advisory CommitteeCV
DecisionSubstantially Equivalent
Device Summary
PICONIBP OEM MODULE is the device name listed in this FDA 510(k) record. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. It received FDA 510(k) clearance on 2005-09-14 under 510(k) number K051366. The device is classified under product code DXN. It was reviewed by the CV advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PICONIBP OEM MODULE?
PICONIBP OEM MODULE is a medical device that received FDA 510(k) clearance on 2005-09-14. The listed applicant is Philips Medizin Systeme Boeblingen GmbH. The 510(k) number is K051366.
When did PICONIBP OEM MODULE receive FDA 510(k) clearance?
PICONIBP OEM MODULE received FDA 510(k) clearance on 2005-09-14, under 510(k) number K051366.
Who is the listed applicant for PICONIBP OEM MODULE?
The FDA 510(k) record lists Philips Medizin Systeme Boeblingen GmbH as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PICONIBP OEM MODULE?
The FDA product code for PICONIBP OEM MODULE is DXN.
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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.