NK Medical Micrometer, Model MC001
FDA 510(k) K921266 · Nk Biotechnical Engineering Co.
510(k) numberK921266
Submission
- Device name
- NK Medical Micrometer, Model MC001
- Applicant
- Nk Biotechnical Engineering Co.
Minneapolis, MN, US - Received
- March 16, 1992
- Decision date
- July 14, 1992
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
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 |
|---|---|---|---|
| K841687 | Skyndex Electronic Body Fat CalculaKTZ · Traditional | Caldwell, Justiss & Co., Inc. | 06/28/1984SE |
| K831898 | ScolimeterKTZ · Traditional | Dr. Micheal A. Sabia | 07/19/1983SE |
| 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 |
|---|---|---|
| K934368 | NK Pressure-Specified Sensory Device, Model PSSD-001LLN · Traditional | 08/11/1994SE |
| K923965 | NK Grasp Sensor, Model GA002LBB · Traditional | 05/12/1993SE |
| K923964 | NK Grasp Sensor, Model GA001LBB · Traditional | 05/12/1993SE |
| K923963 | NK Digi-Grip Sensor, Model DGR001LBB · Traditional | 03/31/1993SE |
| K921268 | NK Dyna-Grip Sensor, Model DG001LBB · Traditional | 07/14/1992SE |
| K914062 | NK Dexteritly Board, Model BX001KQX · Traditional | 12/09/1991SE |
| K914061 | NK Range of Motion Sensor, Model RM002KQX · Traditional | 12/09/1991SE |
| K914060 | Range of Motion Sensor, Model RM001KQX · Traditional | 12/09/1991SE |
| K914059 | NK Deviation Sensor, Model DV001LBB · Traditional | 12/09/1991SE |
| K914057 | NK Pinch Sensor, Model PA001LBB · Traditional | 12/09/1991SE |
Questions and answers
When was NK Medical Micrometer, Model MC001 cleared by the FDA?
NK Medical Micrometer, Model MC001 (K921266) received a 510(k) decision of Substantially Equivalent on July 14, 1992, 120 days after the submission was received.
What is the product code of K921266?
The FDA product code is KTZ – Caliper, a Class I (low risk) device regulated under 21 CFR 888.4150.