Prowler

FDA 510(k) K972037 · The Buzzz Corp.

Substantially Equivalent

510(k) numberK972037

Submission

Device name
Prowler
Applicant
The Buzzz Corp.
Larksville, PA, US
Received
June 2, 1997
Decision date
July 3, 1997
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

Official FDA 510(k) record

Device classification

Product code
INI – Vehicle, Motorized 3-Wheeled
Device class
Class II (moderate risk)
Regulation
21 CFR 890.3800
Specialty
Physical Medicine

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More from Nanjing Mijo Technology Co., Ltd.

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K973373Prevent IINO · Traditional 02/26/1998SE
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Questions and answers

When was Prowler cleared by the FDA?

Prowler (K972037) received a 510(k) decision of Substantially Equivalent on July 3, 1997, 31 days after the submission was received.

What is the product code of K972037?

The FDA product code is INI – Vehicle, Motorized 3-Wheeled, a Class II (moderate risk) device regulated under 21 CFR 890.3800.