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FDA 510(k)

PORTAL GRAVITY SYSTEM

K-Number: K052579 · 2005-09-27

ApplicantPortal, Inc.
Decision Date2005-09-27
Product CodeLNH
Advisory CommitteeRA
DecisionSubstantially Equivalent

Device Summary

PORTAL GRAVITY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Portal, Inc.. It received FDA 510(k) clearance on 2005-09-27 under 510(k) number K052579. The device is classified under product code LNH. It was reviewed by the RA advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PORTAL GRAVITY SYSTEM?

PORTAL GRAVITY SYSTEM is a medical device that received FDA 510(k) clearance on 2005-09-27. The listed applicant is Portal, Inc.. The 510(k) number is K052579.

When did PORTAL GRAVITY SYSTEM receive FDA 510(k) clearance?

PORTAL GRAVITY SYSTEM received FDA 510(k) clearance on 2005-09-27, under 510(k) number K052579.

Who is the listed applicant for PORTAL GRAVITY SYSTEM?

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

What is the FDA product code for PORTAL GRAVITY SYSTEM?

The FDA product code for PORTAL GRAVITY SYSTEM is LNH.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

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