Medtronic Andover Medical Saf-D-Fib Model 1220-002
FDA 510(k) K903018 · Medtronic Andover Medical, Inc.
510(k) numberK903018
Submission
- Device name
- Medtronic Andover Medical Saf-D-Fib Model 1220-002
- Applicant
- Medtronic Andover Medical, Inc.
Haverhill, MA, US - Received
- July 11, 1990
- Decision date
- December 3, 1990
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
Device classification
- Product code
- LDD – Dc-Defibrillator, Low-Energy, (Including Paddles)
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5300
- Specialty
- Cardiovascular
- Life-sustaining
- Yes
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| K102468 | Zoll Propaq MDLDD · Special | Zoll Medical Corporation, World Wide Headquarters | 09/30/2010SE |
More from Zoll Medical Corporation, World Wide Headquarters
| 510(k) | Device | Decision |
|---|---|---|
| K910494 | Resting EKG Electrode SeriesDRX · Traditional | 04/22/1991SE |
| K905446 | Meditronic Andover Medical Model 1690 ElectrodeDRX · Traditional | 02/05/1991SE |
| 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 Medtronic Andover Medical Saf-D-Fib Model 1220-002 cleared by the FDA?
Medtronic Andover Medical Saf-D-Fib Model 1220-002 (K903018) received a 510(k) decision of Substantially Equivalent on December 3, 1990, 145 days after the submission was received.
What is the product code of K903018?
The FDA product code is LDD – Dc-Defibrillator, Low-Energy, (Including Paddles), a Class II (moderate risk) device regulated under 21 CFR 870.5300.