Porta Gas Compressed Gas Cylinder Cart

FDA 510(k) K910071 · Sen Tech Medical Corp.

Substantially Equivalent

510(k) numberK910071

Submission

Device name
Porta Gas Compressed Gas Cylinder Cart
Applicant
Sen Tech Medical Corp.
Mountain View, CA, US
Received
January 9, 1991
Decision date
March 22, 1991
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
GET – Motor, Surgical Instrument, Pneumatic Powered
Device class
Class I (low risk)
Regulation
21 CFR 878.4820
Specialty
General, Plastic Surgery

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Questions and answers

When was Porta Gas Compressed Gas Cylinder Cart cleared by the FDA?

Porta Gas Compressed Gas Cylinder Cart (K910071) received a 510(k) decision of Substantially Equivalent on March 22, 1991, 72 days after the submission was received.

What is the product code of K910071?

The FDA product code is GET – Motor, Surgical Instrument, Pneumatic Powered, a Class I (low risk) device regulated under 21 CFR 878.4820.