Saf-D-Fib
FDA 510(k) K852469 · Medtronic Andover Medical, Inc.
510(k) numberK852469
Submission
- Device name
- Saf-D-Fib
- Applicant
- Medtronic Andover Medical, Inc.
Lowell, MA, US - Received
- June 13, 1985
- Decision date
- September 16, 1985
- 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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| K100129 | Ambu Blue Sensor Neo, Ambu Blue Sensor Neo XDRX · Abbreviated | Ambu A/S | 06/11/2010SE |
| 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 |
|---|---|---|
| K910494 | Resting EKG Electrode SeriesDRX · Traditional | 04/22/1991SE |
| K905446 | Meditronic Andover Medical Model 1690 ElectrodeDRX · Traditional | 02/05/1991SE |
| K903018 | Medtronic Andover Medical Saf-D-Fib Model 1220-002LDD · Traditional | 12/03/1990SE |
| K903554 | Nortech Model 87202204 ElectrodeGXY · Traditional | 08/30/1990SE |
| K882174 | Modified Model 5455 Disposable Surgical CableDSA · Traditional | 07/22/1988SE |
Questions and answers
When was Saf-D-Fib cleared by the FDA?
Saf-D-Fib (K852469) received a 510(k) decision of Substantially Equivalent on September 16, 1985, 95 days after the submission was received.
What is the product code of K852469?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.