Aesthesiometer
FDA 510(k) K874300 · Orthopedic Systems, Inc.
510(k) numberK874300
Submission
- Device name
- Aesthesiometer
- Applicant
- Orthopedic Systems, Inc.
Hayward, CA, US - Received
- October 20, 1987
- Decision date
- November 6, 1987
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Other 510(k)s with product code GWI
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K944234 | TCD or TCD Neuropathy StarGWI · Traditional | Jcm Management & Planning Co. | 03/08/1995SE |
More from Jcm Management & Planning Co.
| 510(k) | Device | Decision |
|---|---|---|
| K952495 | Anchors Away Soft Tissue Attachment SystemLXH · Traditional | 01/22/1996SE |
| K920256 | Spine Motion Analyzer with EmgKQX · Traditional | 08/10/1992SE |
| K910736 | Jackson Multipurpose Operating TableJEA · Traditional | 05/21/1991SE |
| K910031 | Park City Shoulder PositionerFWZ · Traditional | 01/24/1991SE |
| K903938 | C Fit CupJDI · Traditional | 01/04/1991SN |
| K892503 | Nuffield Total KneeJWH · Traditional | 05/04/1990SN |
| K896678 | Silicone PlugHRX · Traditional | 01/30/1990SE |
| K894283 | Comprehensive Spine Motion AnalyzerKQX · Traditional | 01/19/1990SE |
| K890498 | Freeman Modular Hip Stem Ridged VersionJDI · Traditional | 10/13/1989SN |
| K890331 | Freeman Total Hip System Ridged StemLWJ · Traditional | 10/13/1989SE |
Questions and answers
When was Aesthesiometer cleared by the FDA?
Aesthesiometer (K874300) received a 510(k) decision of Substantially Equivalent on November 6, 1987, 17 days after the submission was received.
What is the product code of K874300?
The FDA product code is GWI – Discriminator, Two-Point, a Class I (low risk) device regulated under 21 CFR 882.1200.