Access Cardiosystems Manual Defibrillator
FDA 510(k) K011461 · Access Cardiosystems, Inc.
510(k) numberK011461
Submission
- Device name
- Access Cardiosystems Manual Defibrillator
- Applicant
- Access Cardiosystems, Inc.
Concord, MA, US - Received
- May 14, 2001
- Decision date
- May 28, 2002
- 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
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| K020984 | Accessaed, Semi-Automatic External DefibrillatorsMKJ · Traditional | 08/14/2002ST |
Questions and answers
When was Access Cardiosystems Manual Defibrillator cleared by the FDA?
Access Cardiosystems Manual Defibrillator (K011461) received a 510(k) decision of Substantially Equivalent on May 28, 2002, 379 days after the submission was received.
What is the product code of K011461?
The FDA product code is LDD – Dc-Defibrillator, Low-Energy, (Including Paddles), a Class II (moderate risk) device regulated under 21 CFR 870.5300.