TS-100 Test System
FDA 510(k) K771014 · Delta Medical Industries
510(k) numberK771014
Submission
- Device name
- TS-100 Test System
- Applicant
- Delta Medical Industries
Mchenry, IL, US - Received
- June 6, 1977
- Decision date
- June 14, 1977
- 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 |
| K813358 | Gerard Medical Electrode TesterKRC · Traditional | Gerard Medical Enterprises, Inc. | 12/29/1981SE |
| K780501 | Electrode TesterKRC · Traditional | Mg Medical Electronics | 05/19/1978SE |
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| K830389 | Accu-Rynge Pump SP-250FRN · Traditional | 09/12/1983SE |
| K831750 | PM-3DXS · Traditional | 07/26/1983SE |
| K822761 | Delivery Tube Set #2226FRN · Traditional | 09/30/1982SE |
| K820912 | PMS-2 Pressure Monitor SeparatorDXS · Traditional | 05/18/1982SE |
| K820482 | Accu-Rynge Insulin Pump #SP-250FRN · Traditional | 03/26/1982SE |
| K810068 | Pediatric Arterial Blood FilterDTM · Traditional | 01/22/1981SE |
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Questions and answers
When was TS-100 Test System cleared by the FDA?
TS-100 Test System (K771014) received a 510(k) decision of Substantially Equivalent on June 14, 1977, 8 days after the submission was received.
What is the product code of K771014?
The FDA product code is KRC – Tester, Electrode, Surface, Electrocardiographic, a Class II (moderate risk) device regulated under 21 CFR 870.2370.