Stress Table/Ergometer System
FDA 510(k) K792591 · Victoreen, Inc.
510(k) numberK792591
Submission
- Device name
- Stress Table/Ergometer System
- Applicant
- Victoreen, Inc.
Walker, MI, US - Received
- December 17, 1979
- Decision date
- January 4, 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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| K971382 | Prone Breast Positioning Board, Model #37-018IYE · Traditional | 06/06/1997SE |
| K952233 | Clear-Pb Lead Plastic Overhead Barrier 56-628EAK · Traditional | 06/16/1995SE |
| K940660 | Model 37-720 Dual Diode Dosimetry SystemIYE · Traditional | 12/09/1994SE |
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Questions and answers
When was Stress Table/Ergometer System cleared by the FDA?
Stress Table/Ergometer System (K792591) received a 510(k) decision of Substantially Equivalent on January 4, 1980, 18 days after the submission was received.
What is the product code of K792591?
The FDA product code is ISD – Exerciser, Measuring, a Class II (moderate risk) device regulated under 21 CFR 890.5360.