Aeros Aspirator

FDA 510(k) K952103 · Aeros Instruments, Inc.

Substantially Equivalent

510(k) numberK952103

Submission

Device name
Aeros Aspirator
Applicant
Aeros Instruments, Inc.
Gurnee, IL, US
Received
May 4, 1995
Decision date
July 31, 1995
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)
Summary
510(k) statement available from FDA

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.

510(k)DeviceDecision
K933902Moblvac IIIBTA · Traditional 05/20/1994SE
K934976Instavac IIBTA · Traditional 05/02/1994SE
K932051Tote-L-VacBTA · Traditional 11/12/1993SE
K926566Care-E-VacBTA · Traditional 07/09/1993SESK

Questions and answers

When was Aeros Aspirator cleared by the FDA?

Aeros Aspirator (K952103) received a 510(k) decision of Substantially Equivalent on July 31, 1995, 88 days after the submission was received.

What is the product code of K952103?

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