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FDA 510(k)

TEARLAB OSMOLARITY SYSTEM

K-Number: K083184 · 2009-05-14

ApplicantOcusense, Inc.
Decision Date2009-05-14
Product CodeOND
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

TEARLAB OSMOLARITY SYSTEM is the device name listed in this FDA 510(k) record. The listed applicant is Ocusense, Inc.. It received FDA 510(k) clearance on 2009-05-14 under 510(k) number K083184. The device is classified under product code OND. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TEARLAB OSMOLARITY SYSTEM?

TEARLAB OSMOLARITY SYSTEM is a medical device that received FDA 510(k) clearance on 2009-05-14. The listed applicant is Ocusense, Inc.. The 510(k) number is K083184.

When did TEARLAB OSMOLARITY SYSTEM receive FDA 510(k) clearance?

TEARLAB OSMOLARITY SYSTEM received FDA 510(k) clearance on 2009-05-14, under 510(k) number K083184.

Who is the listed applicant for TEARLAB OSMOLARITY SYSTEM?

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

What is the FDA product code for TEARLAB OSMOLARITY SYSTEM?

The FDA product code for TEARLAB OSMOLARITY SYSTEM is OND.

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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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