InPen Dose Calculator

FDA 510(k) K181327 · Companion Medical, Inc.

Substantially Equivalent

510(k) numberK181327

Submission

Device name
InPen Dose Calculator
Applicant
Companion Medical, Inc.
San Diego, CA, US
Received
May 18, 2018
Decision date
July 6, 2018
Decision
Substantially Equivalent (SESE)
Type
Special 510(k)
Summary
510(k) summary available from FDA

Official FDA 510(k) record

Device classification

Product code
NDC – Calculator, Drug Dose
Device class
Class II (moderate risk)
Regulation
21 CFR 868.1890
Specialty
Anesthesiology

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Questions and answers

When was InPen Dose Calculator cleared by the FDA?

InPen Dose Calculator (K181327) received a 510(k) decision of Substantially Equivalent on July 6, 2018, 49 days after the submission was received.

What is the product code of K181327?

The FDA product code is NDC – Calculator, Drug Dose, a Class II (moderate risk) device regulated under 21 CFR 868.1890.