Deltex Medical Cardioq Edm
FDA 510(k) K111542 · Deltex Medical Limited
510(k) numberK111542
Submission
- Device name
- Deltex Medical Cardioq Edm
- Applicant
- Deltex Medical Limited
Hertsfordshire, GB - Received
- June 2, 2011
- Decision date
- October 20, 2011
- Decision
- Substantially Equivalent (SESE)
- Type
- Traditional 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- DPW – Flowmeter, Blood, Cardiovascular
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 870.2100
- Specialty
- Cardiovascular
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More from Remington Medical, Inc.
| 510(k) | Device | Decision |
|---|---|---|
| K172457 | Deltex Medical CardioQ-EDM+, Deltex Medical CardioQ-EDMDPW · Traditional | 06/28/2018SE |
| K150347 | Deltex Medical CardioQ-EDM, Deltex Medical CardioQ-EDM+DPW · Traditional | 07/24/2015SE |
| K142932 | Deltex Medical KDP72 Doppler ProbeDPT · Traditional | 01/22/2015SE |
| K132139 | Deltex Medical Cardioq-Edm+DPW · Traditional | 10/10/2013SE |
| K073593 | I2S Doppler Probe ( 6 Hour), I2S Doppler Probe (24 Hour), I2C Doppler Probe (72 Hour)…DPT · Traditional | 01/29/2009SE |
| K052989 | DP240 240 Hour Doppler ProbeDPT · Traditional | 03/08/2006SE |
| K031706 | Cardioq, Model 9051-7005DPW · Traditional | 08/06/2003SE |
| K951369 | EdmDPW · Traditional | 11/07/1995SE |
Questions and answers
When was Deltex Medical Cardioq Edm cleared by the FDA?
Deltex Medical Cardioq Edm (K111542) received a 510(k) decision of Substantially Equivalent on October 20, 2011, 140 days after the submission was received.
What is the product code of K111542?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.