Nuclear Stress Table (NST-1)
FDA 510(k) K800892 · Technicare Corp.
510(k) numberK800892
Submission
- Device name
- Nuclear Stress Table (NST-1)
- Applicant
- Technicare Corp.
Mchenry, IL, US - Received
- April 18, 1980
- Decision date
- May 14, 1980
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- ISD – Exerciser, Measuring
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 890.5360
- Specialty
- Physical Medicine
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More from Kinetic Resources, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K854340 | Technicare 720 HPS CT ScannerJAK · Traditional | 11/15/1985SE |
| K852089 | Saturn Nuclear Medicine Computer SystemIYX · Traditional | 07/18/1985SE |
| K844293 | Auto Dii Multi FrequencyIYN · Traditional | 02/13/1985SE |
| K844247 | Ultrasonic Scanner Calibration & Test PhantomsGXX · Traditional | 01/23/1985SE |
| K843716 | Nuclear 700 Medicine Mechanical Posit-IYX · Traditional | 12/17/1984SE |
| K842777 | Autofocus Dual Element ProbeIYO · Traditional | 11/29/1984SE |
| K841817 | Technicare 248 SL & 260SLIYO · Traditional | 08/17/1984SE |
| K840860 | Centauri CT ScannerJAK · Traditional | 05/22/1984SE |
| K840540 | Technicare Model 330IYO · Traditional | 05/09/1984SE |
| K834486 | Technicare 280IYO · Traditional | 04/13/1984SE |
Questions and answers
When was Nuclear Stress Table (NST-1) cleared by the FDA?
Nuclear Stress Table (NST-1) (K800892) received a 510(k) decision of Substantially Equivalent on May 14, 1980, 26 days after the submission was received.
What is the product code of K800892?
The FDA product code is ISD – Exerciser, Measuring, a Class II (moderate risk) device regulated under 21 CFR 890.5360.