Prep-Check
FDA 510(k) K830876 · General Devices
510(k) numberK830876
Submission
- Device name
- Prep-Check
- Applicant
- General Devices
Bergenfield, NJ, US - Received
- March 18, 1983
- Decision date
- May 18, 1983
- 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 |
| K830823 | Z View Meter Model 300KRC · Traditional | Lintronics Industries, Inc. | 05/18/1983SE |
| K813358 | Gerard Medical Electrode TesterKRC · Traditional | Gerard Medical Enterprises, Inc. | 12/29/1981SE |
| 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 |
|---|---|---|
| K013533 | EMS Telemedicine Option (for Gems Series 4000)DRG · Traditional | 01/18/2002SE |
| K002089 | Rosetta-Lt/Rosetta-RxDRG · Traditional | 11/21/2000SE |
| K993202 | EIM-107 Prep-CheckGZO · Traditional | 12/17/1999SE |
| K940009 | Gemscom Series 6000, Models 6100, 6200 & 6300DRG · Traditional | 04/14/1995SE |
| K935839 | Gemscom Series 5000,DRG · Traditional | 11/10/1994SE |
| K921929 | Gemscom Series 300 12-LEAD ECG (12-LEAD Option)DXH · Traditional | 09/18/1992SE |
| K914889 | Gemscom Series 3000DRG · Traditional | 03/04/1992SE |
| K912008 | Tru-View Multi-Channel DisplayDRT · Traditional | 10/09/1991SE |
| K896153 | Modified DR-2C/PMC 100DSH · Traditional | 01/19/1990SE |
| K862596 | DR-2C (Modification)DSF · Traditional | 09/26/1986SE |
Questions and answers
When was Prep-Check cleared by the FDA?
Prep-Check (K830876) received a 510(k) decision of Substantially Equivalent on May 18, 1983, 61 days after the submission was received.
What is the product code of K830876?
The FDA product code is KRC – Tester, Electrode, Surface, Electrocardiographic, a Class II (moderate risk) device regulated under 21 CFR 870.2370.