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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 the device name listed in this FDA 510(k) record. The listed applicant is Ober Consulting Sp. Z.O.O.. It received FDA 510(k) clearance on 2016-08-11 under 510(k) 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. The listed applicant is Ober Consulting Sp. Z.O.O.. The 510(k) number is K152890.

When did SACCADOMETER PLUS, SACCADOMETER ADVANCED receive FDA 510(k) clearance?

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

Who is the listed applicant for SACCADOMETER PLUS, SACCADOMETER ADVANCED?

The FDA 510(k) record lists Ober Consulting Sp. Z.O.O. as the applicant. This does not by itself establish the device manufacturer.

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)

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.

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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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