Acs Model NCP-2
FDA 510(k) K042413 · Applied Cardiac Systems
510(k) numberK042413
Submission
- Device name
- Acs Model NCP-2
- Applicant
- Applied Cardiac Systems
Laguna Hills, CA, US - Received
- September 7, 2004
- Decision date
- December 9, 2004
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DRN – Device, Counter-Pulsating, External
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.5225
- Specialty
- Cardiovascular
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| K082134 | Circulator BootDRN · Traditional | Circulator Boot Corp. | 05/07/2009SE |
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Questions and answers
When was Acs Model NCP-2 cleared by the FDA?
Acs Model NCP-2 (K042413) received a 510(k) decision of Substantially Equivalent on December 9, 2004, 93 days after the submission was received.
What is the product code of K042413?
The FDA product code is DRN – Device, Counter-Pulsating, External, a Class II (moderate risk) device regulated under 21 CFR 870.5225.