Model #911 Stealth Multi Pads
FDA 510(k) K912621 · Cardiotronics, Inc.
510(k) numberK912621
Submission
- Device name
- Model #911 Stealth Multi Pads
- Applicant
- Cardiotronics, Inc.
West Carlsbad, CA, US - Received
- June 13, 1991
- Decision date
- October 16, 1991
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
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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More from Zoll Medical Corporation, World Wide Headquarters
| 510(k) | Device | Decision |
|---|---|---|
| K932903 | EKG VestDRX · Traditional | 02/24/1995SE |
| K922064 | Model #510 Stealth-Plate Dispersive ElectrodeGXD · Traditional | 12/01/1992SE |
| K923297 | Model #340 Stealth-Trode+LsLDD · Traditional | 09/18/1992SE |
| K922227 | Model #225-ST Shock-Trode Adult Defib Pads SterileLDD · Traditional | 06/11/1992SE |
| K922173 | Model # 830 ST Adult Stimulation Pads (Sterile)LDD · Traditional | 06/11/1992SE |
| K922172 | Model # 230 ST Stealth-Trode Defib Pads (Sterile)LDD · Traditional | 06/11/1992SE |
| K921606 | Model #125 Child Stimulation PadsLDD · Traditional | 05/26/1992SE |
| K920086 | Shock-Patch Adult Defibrillation PadsLDD · Traditional | 02/03/1992SE |
| K914725 | Coordinator, Cable InputDPS · Traditional | 11/05/1991SE |
| K911456 | Model #110 Stealth-Trode Child Defib PadsLDD · Traditional | 10/16/1991SE |
Questions and answers
When was Model #911 Stealth Multi Pads cleared by the FDA?
Model #911 Stealth Multi Pads (K912621) received a 510(k) decision of Substantially Equivalent on October 16, 1991, 125 days after the submission was received.
What is the product code of K912621?
The FDA product code is LDD – Dc-Defibrillator, Low-Energy, (Including Paddles), a Class II (moderate risk) device regulated under 21 CFR 870.5300.