Z View Meter Model 300
FDA 510(k) K830823 · Lintronics Industries, Inc.
510(k) numberK830823
Submission
- Device name
- Z View Meter Model 300
- Applicant
- Lintronics Industries, Inc.
Walker, MI, US - Received
- March 15, 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 |
| K830876 | Prep-CheckKRC · Traditional | General Devices | 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 |
Questions and answers
When was Z View Meter Model 300 cleared by the FDA?
Z View Meter Model 300 (K830823) received a 510(k) decision of Substantially Equivalent on May 18, 1983, 64 days after the submission was received.
What is the product code of K830823?
The FDA product code is KRC – Tester, Electrode, Surface, Electrocardiographic, a Class II (moderate risk) device regulated under 21 CFR 870.2370.