ASA01 Heavy Duty Suction Pump

FDA 510(k) K071607 · Zhongshan A&J Medical Equipment Co., Ltd.

Substantially Equivalent

510(k) numberK071607

Submission

Device name
ASA01 Heavy Duty Suction Pump
Applicant
Zhongshan A&J Medical Equipment Co., Ltd.
Guangdong, CN
Received
June 12, 2007
Decision date
June 26, 2007
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) summary available from FDA
Third-party review
Yes

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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Questions and answers

When was ASA01 Heavy Duty Suction Pump cleared by the FDA?

ASA01 Heavy Duty Suction Pump (K071607) received a 510(k) decision of Substantially Equivalent on June 26, 2007, 14 days after the submission was received.

What is the product code of K071607?

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