Pocket Aid

FDA 510(k) K832702 · M.C. Johnson Co., Inc.

Substantially Equivalent

510(k) numberK832702

Submission

Device name
Pocket Aid
Applicant
M.C. Johnson Co., Inc.
Walker, MI, US
Received
August 11, 1983
Decision date
November 17, 1983
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
LDR – Controller, Infusion, Intravascular, Electronic
Device class
Class II (moderate risk)
Regulation
21 CFR 880.5725
Specialty
General Hospital

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K934543Universal Controller, Model 100LDR · Traditional Metamed, Inc.03/29/1994SE
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K905498Stat 2 IV PumpetteLDR · Traditional The Master Medical Corp.04/16/1991SE
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More from The Master Medical Corp.

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Questions and answers

When was Pocket Aid cleared by the FDA?

Pocket Aid (K832702) received a 510(k) decision of Substantially Equivalent on November 17, 1983, 98 days after the submission was received.

What is the product code of K832702?

The FDA product code is LDR – Controller, Infusion, Intravascular, Electronic, a Class II (moderate risk) device regulated under 21 CFR 880.5725.