Am-Pak
FDA 510(k) K912436 · Cns, Inc.
510(k) numberK912436
Submission
- Device name
- Am-Pak
- Applicant
- Cns, Inc.
Chanhassen, MN, US - Received
- June 3, 1991
- Decision date
- October 18, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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| K901549 | CNS Satellite 100, 200, 1000, 2000 Electroence.GWQ · Traditional | 10/24/1990SE |
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Questions and answers
When was Am-Pak cleared by the FDA?
Am-Pak (K912436) received a 510(k) decision of Substantially Equivalent on October 18, 1991, 137 days after the submission was received.
What is the product code of K912436?
The FDA product code is GWL – Amplifier, Physiological Signal, a Class II (moderate risk) device regulated under 21 CFR 882.1835.