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FDA 510(k)

PORTAGE System

K-Number: K161878 · 2016-09-26

ApplicantBaylis Medical Company, Inc.
Decision Date2016-09-26
Product CodeHRX
Advisory CommitteeOR
DecisionSubstantially Equivalent

Device Summary

PORTAGE System is the device name listed in this FDA 510(k) record. The listed applicant is Baylis Medical Company, Inc.. It received FDA 510(k) clearance on 2016-09-26 under 510(k) number K161878. The device is classified under product code HRX. It was reviewed by the OR advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTAGE System?

PORTAGE System is a medical device that received FDA 510(k) clearance on 2016-09-26. The listed applicant is Baylis Medical Company, Inc.. The 510(k) number is K161878.

When did PORTAGE System receive FDA 510(k) clearance?

PORTAGE System received FDA 510(k) clearance on 2016-09-26, under 510(k) number K161878.

Who is the listed applicant for PORTAGE System?

The FDA 510(k) record lists Baylis Medical Company, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for PORTAGE System?

The FDA product code for PORTAGE System is HRX.

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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.

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