Sentry Radiotranslucent ECG Electrodes
FDA 510(k) K962122 · Sentry Medical Products, Inc.
510(k) numberK962122
Submission
- Device name
- Sentry Radiotranslucent ECG Electrodes
- Applicant
- Sentry Medical Products, Inc.
Lombard, IL, US - Received
- May 31, 1996
- Decision date
- July 24, 1996
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) statement available from FDA
Device classification
- Product code
- DRX – Electrode, Electrocardiograph
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2360
- Specialty
- Cardiovascular
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More from Suzuken Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K955636 | Sentry Disposable Dispersive ElectrodeJOS · Traditional | 03/27/1996SE |
| K942827 | Sentry Insertion TrayFOS · Traditional | 11/02/1994SE |
| K934000 | Sentry Aqueous Gel ECG ElectrodesDRX · Traditional | 08/30/1994SE |
| K935098 | Baby BoardBTX · Traditional | 02/15/1994SE |
| K933603 | LeadwireDSA · Traditional | 01/18/1994SE |
| K932704 | Patient CableDSA · Traditional | 12/27/1993SE |
| K881670 | Accutemp PlusFMT · Traditional | 11/22/1988SE |
| K881343 | Duraderm ButterflyGXY · Traditional | 05/04/1988SE |
| K851522 | Diagnostic ECG Disposable ElectrodeDRX · Traditional | 10/24/1985SE |
| K853552 | Sentry Flexible TENSGXY · Traditional | 09/26/1985SE |
Questions and answers
When was Sentry Radiotranslucent ECG Electrodes cleared by the FDA?
Sentry Radiotranslucent ECG Electrodes (K962122) received a 510(k) decision of Substantially Equivalent on July 24, 1996, 54 days after the submission was received.
What is the product code of K962122?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.