Nerve Stimulator Model Aa 1050

FDA 510(k) K811614 · Anesthesia Assoc., Inc.

Substantially Equivalent

510(k) numberK811614

Submission

Device name
Nerve Stimulator Model Aa 1050
Applicant
Anesthesia Assoc., Inc.
Mchenry, IL, US
Received
June 8, 1981
Decision date
June 18, 1981
Decision
Substantially Equivalent (SESE)
Type
Traditional 510(k)

Official FDA 510(k) record

Device classification

Product code
BXN – Stimulator, Nerve, Battery-Powered
Device class
Class II (moderate risk)
Regulation
21 CFR 868.2775
Specialty
Anesthesiology

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K121743Easymed Peripheral Nerve Stimulator-SunstinBXN · Traditional Sunmed, LLC03/28/2013SE
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K093591Stimpod Model NMS-400 Nerve StimulatorBXN · Traditional Xavant Technology (Pty), Ltd.12/03/2009SE

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Questions and answers

When was Nerve Stimulator Model Aa 1050 cleared by the FDA?

Nerve Stimulator Model Aa 1050 (K811614) received a 510(k) decision of Substantially Equivalent on June 18, 1981, 10 days after the submission was received.

What is the product code of K811614?

The FDA product code is BXN – Stimulator, Nerve, Battery-Powered, a Class II (moderate risk) device regulated under 21 CFR 868.2775.