Model 200
FDA 510(k) K830468 · Western Laboratories Corp.
510(k) numberK830468
Submission
- Device name
- Model 200
- Applicant
- Western Laboratories Corp.
Mchenry, IL, US - Received
- February 15, 1983
- Decision date
- April 12, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- FTZ – Locator, Magnetic
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 886.4445
- Specialty
- Ophthalmic
Other 510(k)s with product code FTZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K833229 | Sun Bed by Verre Et Quartz Uva-FranceFTZ · Traditional | H & M Douglas Enterprises, Inc. | 01/27/1984SE |
More from H & M Douglas Enterprises, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K834024 | HeparinometerKFF · Traditional | 06/11/1984SE |
| K821834 | Model 100 Bicarbonate ConductivityFKQ · Traditional | 07/02/1982SE |
| K821415 | Model 90 BCFLB · Traditional | 05/27/1982SE |
| K821414 | Model 80 BC · Traditional | 05/27/1982SE |
| K801303 | Model 90 Pressure/Conductivity/Temp TestKDI · Traditional | 07/28/1980SE |
| K780932 | Model 80 Conductivity/Temp.Test UnitFIZ · Traditional | 08/31/1978SE |
Questions and answers
When was Model 200 cleared by the FDA?
Model 200 (K830468) received a 510(k) decision of Substantially Equivalent on April 12, 1983, 56 days after the submission was received.
What is the product code of K830468?
The FDA product code is FTZ – Locator, Magnetic, a Class I (low risk) device regulated under 21 CFR 886.4445.