Correstore Patch, Models 1.5P2, 2P3, 3P4; Correstore Sizer, Model CRPS
FDA 510(k) K011487 · Somanetics Corp.
510(k) numberK011487
Submission
- Device name
- Correstore Patch, Models 1.5P2, 2P3, 3P4; Correstore Sizer, Model CRPS
- Applicant
- Somanetics Corp.
Troy, MI, US - Received
- May 15, 2001
- Decision date
- November 21, 2001
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DXZ – Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.3470
- Specialty
- Cardiovascular
- Implant
- Yes
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| K040162 | Correstore Patch SystemDXZ · Traditional | 03/16/2004SE |
| K031586 | Correstore Patch SystemDXZ · Traditional | 08/07/2003SE |
| K001842 | Adult/Pediatric Cerebral Oximeter, Model Invos 5100DQA · Traditional | 09/15/2000SE |
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Questions and answers
When was Correstore Patch, Models 1.5P2, 2P3, 3P4; Correstore Sizer, Model CRPS cleared by the FDA?
Correstore Patch, Models 1.5P2, 2P3, 3P4; Correstore Sizer, Model CRPS (K011487) received a 510(k) decision of Substantially Equivalent on November 21, 2001, 190 days after the submission was received.
What is the product code of K011487?
The FDA product code is DXZ – Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene, a Class II (moderate risk) device regulated under 21 CFR 870.3470.