Scolimeter
FDA 510(k) K831898 · Dr. Micheal A. Sabia
510(k) numberK831898
Submission
- Device name
- Scolimeter
- Applicant
- Dr. Micheal A. Sabia
Mchenry, IL, US - Received
- June 14, 1983
- Decision date
- July 19, 1983
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- KTZ – Caliper
- Device class
- Class I (low risk)
- Regulation
- 21 CFR 888.4150
- Specialty
- Orthopedic
Other 510(k)s with product code KTZ
| 510(k) | Device | Applicant | Decision |
|---|---|---|---|
| K921266 | NK Medical Micrometer, Model MC001KTZ · Traditional | Nk Biotechnical Engineering Co. | 07/14/1992SE |
| K841687 | Skyndex Electronic Body Fat CalculaKTZ · Traditional | Caldwell, Justiss & Co., Inc. | 06/28/1984SE |
| K820659 | A CaliperKTZ · Traditional | Twin City Surgical, Inc. | 03/19/1982SE |
| K810116 | Isorobic Skinfold CaliperKTZ · Traditional | Fitness Motivation Institute of America | 02/04/1981SE |
| K800363 | Parke-Davis Total Knee ProsthesisKTZ · Traditional | Warner-Lambert Co. | 03/10/1980SE |
| K760521 | Tape MeasureKTZ · Traditional | Mcgaw Laboratories | 11/12/1976SE |
More from Mcgaw Laboratories
| 510(k) | Device | Decision |
|---|---|---|
| K831899 | EnswellIME · Traditional | 07/07/1983SE |
Questions and answers
When was Scolimeter cleared by the FDA?
Scolimeter (K831898) received a 510(k) decision of Substantially Equivalent on July 19, 1983, 35 days after the submission was received.
What is the product code of K831898?
The FDA product code is KTZ – Caliper, a Class I (low risk) device regulated under 21 CFR 888.4150.