Gerard Medical Electrode Tester
FDA 510(k) K813358 · Gerard Medical Enterprises, Inc.
510(k) numberK813358
Submission
- Device name
- Gerard Medical Electrode Tester
- Applicant
- Gerard Medical Enterprises, Inc.
Mchenry, IL, US - Received
- November 30, 1981
- Decision date
- December 29, 1981
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KRC – Tester, Electrode, Surface, Electrocardiographic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2370
- Specialty
- Cardiovascular
Other 510(k)s with product code KRC
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K023713 | Sonoprep Impedance Diagnostics (Idx) System, Model D1000KRC · Traditional | Sontra Medical, Inc. | 01/28/2004SE |
| K872370 | Bioma 3500KRC · Traditional | E.B.S., Inc. | 12/07/1987SE |
| K874327 | Skin Prep AnalyzerKRC · Traditional | Marquette Electronics, Inc. | 11/23/1987SE |
| K874155 | Circamed Monitor Remote Start Conductance MeterKRC · Traditional | Circadian, Inc. | 11/23/1987SE |
| K840358 | IMPEDANCE/8200 Monitor-Model 8300KRC · Traditional | Aequitron Medical, Inc. | 10/30/1984SE |
| K833619 | Conductance MeterKRC · Traditional | Circadian, Inc. | 01/27/1984SE |
| K830876 | Prep-CheckKRC · Traditional | General Devices | 05/18/1983SE |
| K830823 | Z View Meter Model 300KRC · Traditional | Lintronics Industries, Inc. | 05/18/1983SE |
| K780501 | Electrode TesterKRC · Traditional | Mg Medical Electronics | 05/19/1978SE |
| K771014 | TS-100 Test SystemKRC · Traditional | Delta Medical Industries | 06/14/1977SE |
More from Delta Medical Industries
| 510(k) | Device | Decision |
|---|---|---|
| K954258 | Trimport Implantable Access System (Modification)LJT · Traditional | 05/24/1996SE |
| K945250 | TrimportLJT · Traditional | 03/07/1995SE |
| K942623 | TrimportLJT · Traditional | 08/23/1994SE |
| K922147 | Dual Plastic Vascular Access SystemLJT · Traditional | 12/04/1992SE |
| K913114 | Trim-Port(Tm) Implant Access Syst Dual Titan PortFMF · Traditional | 01/02/1992SESK |
| K912111 | Modified Version Implantable Vascular Access SysteFMF · Traditional | 10/08/1991SE |
| K903364 | Gerard Medical, Inc. Trim-PortLJT · Traditional | 10/31/1990SESK |
Questions and answers
When was Gerard Medical Electrode Tester cleared by the FDA?
Gerard Medical Electrode Tester (K813358) received a 510(k) decision of Substantially Equivalent on December 29, 1981, 29 days after the submission was received.
What is the product code of K813358?
The FDA product code is KRC – Tester, Electrode, Surface, Electrocardiographic, a Class II (moderate risk) device regulated under 21 CFR 870.2370.