Moorvms-Pres Pressure Cuff Controller
FDA 510(k) K102433 · Moor Instruments, Ltd.
510(k) numberK102433
Submission
- Device name
- Moorvms-Pres Pressure Cuff Controller
- Applicant
- Moor Instruments, Ltd.
Axminster, Devon, GB - Received
- August 26, 2010
- Decision date
- November 18, 2010
- 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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Questions and answers
When was Moorvms-Pres Pressure Cuff Controller cleared by the FDA?
Moorvms-Pres Pressure Cuff Controller (K102433) received a 510(k) decision of Substantially Equivalent on November 18, 2010, 84 days after the submission was received.
What is the product code of K102433?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.