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FDA 510(k)

POINTE 750 GLYCOMETER

K-Number: K920449 · 1992-07-28

ApplicantPointe Scientific, Inc.,
Decision Date1992-07-28
Product CodeLCP
Advisory CommitteeHE
DecisionSubstantially Equivalent

Device Summary

POINTE 750 GLYCOMETER 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 1992-07-28 under 510(k) number K920449. The device is classified under product code LCP. It was reviewed by the HE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the POINTE 750 GLYCOMETER?

POINTE 750 GLYCOMETER is a medical device that received FDA 510(k) clearance on 1992-07-28. The listed applicant is Pointe Scientific, Inc.,. The 510(k) number is K920449.

When did POINTE 750 GLYCOMETER receive FDA 510(k) clearance?

POINTE 750 GLYCOMETER received FDA 510(k) clearance on 1992-07-28, under 510(k) number K920449.

Who is the listed applicant for POINTE 750 GLYCOMETER?

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 750 GLYCOMETER?

The FDA product code for POINTE 750 GLYCOMETER is LCP.

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Other records listing Pointe Scientific, Inc., as applicant

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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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