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FDA 510(k)

PAIN VISION, MODEL PS-2100

K-Number: K072882 · 2009-01-08

ApplicantOsachi Co., Ltd.
Decision Date2009-01-08
Product CodeLLN
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

PAIN VISION, MODEL PS-2100 is the device name listed in this FDA 510(k) record. The listed applicant is Osachi Co., Ltd.. It received FDA 510(k) clearance on 2009-01-08 under 510(k) number K072882. The device is classified under product code LLN. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the PAIN VISION, MODEL PS-2100?

PAIN VISION, MODEL PS-2100 is a medical device that received FDA 510(k) clearance on 2009-01-08. The listed applicant is Osachi Co., Ltd.. The 510(k) number is K072882.

When did PAIN VISION, MODEL PS-2100 receive FDA 510(k) clearance?

PAIN VISION, MODEL PS-2100 received FDA 510(k) clearance on 2009-01-08, under 510(k) number K072882.

Who is the listed applicant for PAIN VISION, MODEL PS-2100?

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

What is the FDA product code for PAIN VISION, MODEL PS-2100?

The FDA product code for PAIN VISION, MODEL PS-2100 is LLN.

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Related Devices (Code: LLN)

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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.

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