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FDA 510(k)

POINTER PLUS

K-Number: K060508 · 2006-06-19

ApplicantLhasa Oms, Inc.
Decision Date2006-06-19
Product CodeGZJ
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

POINTER PLUS is the device name listed in this FDA 510(k) record. The listed applicant is Lhasa Oms, Inc.. It received FDA 510(k) clearance on 2006-06-19 under 510(k) number K060508. The device is classified under product code GZJ. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POINTER PLUS?

POINTER PLUS is a medical device that received FDA 510(k) clearance on 2006-06-19. The listed applicant is Lhasa Oms, Inc.. The 510(k) number is K060508.

When did POINTER PLUS receive FDA 510(k) clearance?

POINTER PLUS received FDA 510(k) clearance on 2006-06-19, under 510(k) number K060508.

Who is the listed applicant for POINTER PLUS?

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

What is the FDA product code for POINTER PLUS?

The FDA product code for POINTER PLUS is GZJ.

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Other records listing Lhasa Oms, Inc. as applicant

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Related Devices (Code: GZJ)

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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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