Meditronic Andover Medical Model 1690 Electrode
FDA 510(k) K905446 · Medtronic Andover Medical, Inc.
510(k) numberK905446
Submission
- Device name
- Meditronic Andover Medical Model 1690 Electrode
- Applicant
- Medtronic Andover Medical, Inc.
Haverhill, MA, US - Received
- December 5, 1990
- Decision date
- February 5, 1991
- 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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More from Suzuken Co., Ltd.
| 510(k) | Device | Decision |
|---|---|---|
| K910494 | Resting EKG Electrode SeriesDRX · Traditional | 04/22/1991SE |
| 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 |
| K852469 | Saf-D-FibDRX · Traditional | 09/16/1985SE |
Questions and answers
When was Meditronic Andover Medical Model 1690 Electrode cleared by the FDA?
Meditronic Andover Medical Model 1690 Electrode (K905446) received a 510(k) decision of Substantially Equivalent on February 5, 1991, 62 days after the submission was received.
What is the product code of K905446?
The FDA product code is DRX – Electrode, Electrocardiograph, a Class II (moderate risk) device regulated under 21 CFR 870.2360.