Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR, NMPA) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

SACCADOMETER PLUS, SACCADOMETER ADVANCED

K-Number: K152890 · 2016-08-11

ApplicantOber Consulting Sp. Z.O.O.
Decision Date2016-08-11
Product CodeHLL
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

SACCADOMETER PLUS, SACCADOMETER ADVANCED is a medical device manufactured by Ober Consulting Sp. Z.O.O.. It received FDA 510(k) clearance on 2016-08-11 under approval number K152890. The device is classified under product code HLL. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the SACCADOMETER PLUS, SACCADOMETER ADVANCED?

SACCADOMETER PLUS, SACCADOMETER ADVANCED is a medical device that received FDA 510(k) clearance on 2016-08-11. It is manufactured by Ober Consulting Sp. Z.O.O.. The 510(k) number is K152890.

When was SACCADOMETER PLUS, SACCADOMETER ADVANCED approved by the FDA?

SACCADOMETER PLUS, SACCADOMETER ADVANCED received FDA 510(k) clearance on 2016-08-11, under approval number K152890.

What company makes SACCADOMETER PLUS, SACCADOMETER ADVANCED?

SACCADOMETER PLUS, SACCADOMETER ADVANCED is manufactured by Ober Consulting Sp. Z.O.O..

What is the FDA product code for SACCADOMETER PLUS, SACCADOMETER ADVANCED?

The FDA product code for SACCADOMETER PLUS, SACCADOMETER ADVANCED is HLL.

Related Devices (Code: HLL)

K222484RetitrackC. Light Technologies, Inc.

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.

↑