Syncor (R) Model S-801 ECG Electrode
FDA 510(k) K882216 · Lectec Corp.
510(k) numberK882216
Submission
- Device name
- Syncor (R) Model S-801 ECG Electrode
- Applicant
- Lectec Corp.
Minnetonka, MN, US - Received
- May 26, 1988
- Decision date
- July 20, 1988
- 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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| K904512 | Tracet AG 4000DRX · Traditional | 01/31/1991SE |
| K893425 | VitatraceDRX · Traditional | 07/14/1989SE |
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Questions and answers
When was Syncor (R) Model S-801 ECG Electrode cleared by the FDA?
Syncor (R) Model S-801 ECG Electrode (K882216) received a 510(k) decision of Substantially Equivalent on July 20, 1988, 55 days after the submission was received.
What is the product code of K882216?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.