Tote-L-Vac

FDA 510(k) K932051 · Aeros Instruments, Inc.

Substantially Equivalent

510(k) numberK932051

Submission

Device name
Tote-L-Vac
Applicant
Aeros Instruments, Inc.
Northbrook, IL, US
Received
April 27, 1993
Decision date
November 12, 1993
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
K952103Aeros AspiratorBTA · Traditional 07/31/1995SE
K933902Moblvac IIIBTA · Traditional 05/20/1994SE
K934976Instavac IIBTA · Traditional 05/02/1994SE
K926566Care-E-VacBTA · Traditional 07/09/1993SESK

Questions and answers

When was Tote-L-Vac cleared by the FDA?

Tote-L-Vac (K932051) received a 510(k) decision of Substantially Equivalent on November 12, 1993, 199 days after the submission was received.

What is the product code of K932051?

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