Classic Ecg/Stimulating No. 1700 Series
FDA 510(k) K900519 · Classic Medical Products, Inc.
510(k) numberK900519
Submission
- Device name
- Classic Ecg/Stimulating No. 1700 Series
- Applicant
- Classic Medical Products, Inc.
Muskego, WI, US - Received
- February 2, 1990
- Decision date
- March 19, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- DRX – Electrode, Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2360
- Specialty
- Cardiovascular
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| K093327 | Intco Tab ElectrodeDRX · Abbreviated | Shanghai Intco Electrode Manufacturing Co., Ltd. | 05/10/2010SE |
| K100315 | 12 Lead GloveDRX · Special | I Needmd, Inc. | 04/23/2010SE |
| K092744 | Neonatal ECG Electrode, M203KENDRX · Traditional | R & D Medical Products, Inc. | 12/10/2009SE |
| K092389 | Disposal ECG Electrodes, Model EasyrodeDRX · Traditional | Suzuken Co., Ltd. | 10/13/2009SE |
More from Suzuken Co., Ltd.
| 510(k) | Device | Decision |
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| K862953 | Classic Resting Silver-Silverchloride ElectrodeDRY · Traditional | 08/25/1986SE |
Questions and answers
When was Classic Ecg/Stimulating No. 1700 Series cleared by the FDA?
Classic Ecg/Stimulating No. 1700 Series (K900519) received a 510(k) decision of Substantially Equivalent on March 19, 1990, 45 days after the submission was received.
What is the product code of K900519?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.