Bypass Leg Positioner

FDA 510(k) K932186 · Voss Medical Products

Substantially Equivalent

510(k) numberK932186

Submission

Device name
Bypass Leg Positioner
Applicant
Voss Medical Products
Washington, DC, US
Received
May 5, 1993
Decision date
June 1, 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
FQO – Table, Operating-Room, Ac-Powered
Device class
Class I (low risk)
Regulation
21 CFR 878.4960
Specialty
General, Plastic Surgery

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K961886Drager Gemina Wall-Mounted WorkplaceFQO · Traditional Alm Surgical Equipment, Inc.07/30/1996SE
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More from Berchtold Holding GmbH

510(k)DeviceDecision
K932187Prone PositionerKIL · Traditional 06/01/1993SE
K896338Voss Disposable Coronary Bypass Flushing CannulaDWF · Traditional 05/17/1990SE
K885161Voss Vein ClampDXC · Traditional 12/22/1989SE
K895369Voss Graft MarkerKPK · Traditional 09/27/1989SE

Questions and answers

When was Bypass Leg Positioner cleared by the FDA?

Bypass Leg Positioner (K932186) received a 510(k) decision of Substantially Equivalent on June 1, 1993, 27 days after the submission was received.

What is the product code of K932186?

The FDA product code is FQO – Table, Operating-Room, Ac-Powered, a Class I (low risk) device regulated under 21 CFR 878.4960.