PreOp
K-Number: K172858 · 2018-01-08
ApplicantEpilog
Decision Date2018-01-08
Product CodeOLX
Advisory CommitteeNE
DecisionSubstantially Equivalent
Device Summary
PreOp is the device name listed in this FDA 510(k) record. The listed applicant is Epilog. It received FDA 510(k) clearance on 2018-01-08 under 510(k) number K172858. The device is classified under product code OLX. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.
Frequently Asked Questions
What is the PreOp?
PreOp is a medical device that received FDA 510(k) clearance on 2018-01-08. The listed applicant is Epilog. The 510(k) number is K172858.
When did PreOp receive FDA 510(k) clearance?
PreOp received FDA 510(k) clearance on 2018-01-08, under 510(k) number K172858.
Who is the listed applicant for PreOp?
The FDA 510(k) record lists Epilog as the applicant. This does not by itself establish the device manufacturer.
What is the FDA product code for PreOp?
The FDA product code for PreOp is OLX.
Related Devices (Code: OLX)
Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.
Official Source
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