Sc-It Impedance Tester
FDA 510(k) K820040 · Cadwell Laboratories, Inc.
510(k) numberK820040
Submission
- Device name
- Sc-It Impedance Tester
- Applicant
- Cadwell Laboratories, Inc.
Mchenry, IL, US - Received
- January 7, 1982
- Decision date
- January 28, 1982
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code GYA
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K883869 | DermtrodeGYA · Traditional | World Precision Instruments, Inc. | 09/30/1988SE |
| K854396 | Rub E-ZGYA · Traditional | E-Z Instruments Co. | 05/08/1986SE |
| K830877 | Ap-CheckGYA · Traditional | General Devices | 06/08/1983SE |
| K781475 | Electrode Impedance Tester-Model 500GYA · Traditional | Life-Tech Instruments, Inc. | 09/07/1978SE |
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| K971214 | KilowinGWE · Traditional | 06/11/1998SE |
| K962458 | Cadwell Four-/Eight-Channel PreamplifierGWF · Traditional | 01/13/1997SE |
| K962457 | Two-Channel PreamplifierGWF · Traditional | 01/13/1997SE |
| K962455 | Four-Channel PreamplifierGWF · Traditional | 01/13/1997SE |
| K946094 | Cadwell Easy Ambulatory EEGGWQ · Traditional | 09/12/1995SE |
Questions and answers
When was Sc-It Impedance Tester cleared by the FDA?
Sc-It Impedance Tester (K820040) received a 510(k) decision of Substantially Equivalent on January 28, 1982, 21 days after the submission was received.
What is the product code of K820040?
The FDA product code is GYA – Tester, Electrode/Lead, Electroencephalograph, a Class I (low risk) device regulated under 21 CFR 882.1410.