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FDA 510(k)

POINTE 360

K-Number: K062118 · 2007-07-13

ApplicantPointe Scientific, Inc.,
Decision Date2007-07-13
Product CodeCFR
Advisory CommitteeCH
DecisionSubstantially Equivalent

Device Summary

POINTE 360 is the device name listed in this FDA 510(k) record. The listed applicant is Pointe Scientific, Inc.,. It received FDA 510(k) clearance on 2007-07-13 under 510(k) number K062118. The device is classified under product code CFR. It was reviewed by the CH advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POINTE 360?

POINTE 360 is a medical device that received FDA 510(k) clearance on 2007-07-13. The listed applicant is Pointe Scientific, Inc.,. The 510(k) number is K062118.

When did POINTE 360 receive FDA 510(k) clearance?

POINTE 360 received FDA 510(k) clearance on 2007-07-13, under 510(k) number K062118.

Who is the listed applicant for POINTE 360?

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

What is the FDA product code for POINTE 360?

The FDA product code for POINTE 360 is CFR.

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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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