K.M. Products Aspirator

FDA 510(k) K844200 · Km Products

Substantially Equivalent

510(k) numberK844200

Submission

Device name
K.M. Products Aspirator
Applicant
Km Products
Tucson, AZ, US
Received
October 30, 1984
Decision date
January 25, 1985
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BTA – Pump, Portable, Aspiration (Manual Or Powered)
Device class
Class II (moderate risk)
Regulation
21 CFR 878.4780
Specialty
General, Plastic Surgery

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More from Shenzhen Kingboom Technology Co., Ltd.

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K850105KM Products Aspirating TubingBSY · Traditional 03/21/1985SE
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Questions and answers

When was K.M. Products Aspirator cleared by the FDA?

K.M. Products Aspirator (K844200) received a 510(k) decision of Substantially Equivalent on January 25, 1985, 87 days after the submission was received.

What is the product code of K844200?

The FDA product code is BTA – Pump, Portable, Aspiration (Manual Or Powered), a Class II (moderate risk) device regulated under 21 CFR 878.4780.