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FDA 510(k)

INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER

K-Number: K082512 · 2008-11-07

ApplicantDimensional Dosing Systems, Inc.
Decision Date2008-11-07
Product CodeNDC
Advisory CommitteeAN
DecisionSubstantially Equivalent

Device Summary

INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER is the device name listed in this FDA 510(k) record. The listed applicant is Dimensional Dosing Systems, Inc.. It received FDA 510(k) clearance on 2008-11-07 under 510(k) number K082512. The device is classified under product code NDC. It was reviewed by the AN advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER?

INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER is a medical device that received FDA 510(k) clearance on 2008-11-07. The listed applicant is Dimensional Dosing Systems, Inc.. The 510(k) number is K082512.

When did INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER receive FDA 510(k) clearance?

INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER received FDA 510(k) clearance on 2008-11-07, under 510(k) number K082512.

Who is the listed applicant for INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER?

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

What is the FDA product code for INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER?

The FDA product code for INTELLIGENT DOSING SYSTEM FOR INSULIN-MY INSULIN DOSER is NDC.

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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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