COR12+
FDA 510(k) K091505 · Viasys Healthcare GmbH
510(k) numberK091505
Submission
- Device name
- COR12+
- Applicant
- Viasys Healthcare GmbH
Hoechberg, DE - Received
- May 21, 2009
- Decision date
- June 10, 2009
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
- Third-party review
- Yes
Device classification
- Product code
- DSH – Recorder, Magnetic Tape, Medical
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2800
- Specialty
- Cardiovascular
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| K072323 | Masterscreen & Oxycon CPXBZC · Special | 10/10/2007SE |
| K071753 | Masterscreen Pneumo & MasterscopeBTY · Special | 08/14/2007SE |
| K062011 | Modification to FlowscreenBTY · Special | 05/11/2007SE |
| K070614 | CorscreenDPS · Traditional | 05/04/2007SE |
Questions and answers
When was COR12+ cleared by the FDA?
COR12+ (K091505) received a 510(k) decision of Substantially Equivalent on June 10, 2009, 20 days after the submission was received.
What is the product code of K091505?
The FDA product code is DSH – Recorder, Magnetic Tape, Medical, a Class II (moderate risk) device regulated under 21 CFR 870.2800.