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FDA 510(k)

Perfectio LED infrared device

K-Number: K152332 · 2016-02-25

ApplicantOmm Imports Inc Dba Zero Gravity
Decision Date2016-02-25
Product CodeOHS
Advisory CommitteeSU
DecisionSubstantially Equivalent

Device Summary

Perfectio LED infrared device is a medical device manufactured by Omm Imports Inc Dba Zero Gravity. It received FDA 510(k) clearance on 2016-02-25 under approval number K152332. The device is classified under product code OHS. It was reviewed by the SU advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Perfectio LED infrared device?

Perfectio LED infrared device is a medical device that received FDA 510(k) clearance on 2016-02-25. It is manufactured by Omm Imports Inc Dba Zero Gravity. The 510(k) number is K152332.

When was Perfectio LED infrared device approved by the FDA?

Perfectio LED infrared device received FDA 510(k) clearance on 2016-02-25, under approval number K152332.

What company makes Perfectio LED infrared device?

Perfectio LED infrared device is manufactured by Omm Imports Inc Dba Zero Gravity.

What is the FDA product code for Perfectio LED infrared device?

The FDA product code for Perfectio LED infrared device is OHS.

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Related PubMed Literature

PMID: 41336744 From laboratory to pre-market prototyping: lessons learned from a noninvasive blood glucose level measurement device. Annual International Conference of the IEEE Engineering in Medicine and Biology Society. IEEE Engineering in Medicine and Biology Society. Annual International Conference (2025)

Related Devices (Code: OHS)

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Official Source

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