Quantix/Or Blood Flow Monitor; Flexible Probe with Optional Vessel Stabilizer
FDA 510(k) K050088 · Neoprobe Corp.
510(k) numberK050088
Submission
- Device name
- Quantix/Or Blood Flow Monitor; Flexible Probe with Optional Vessel Stabilizer
- Applicant
- Neoprobe Corp.
Dublin, OH, US - Received
- January 13, 2005
- Decision date
- February 8, 2005
- Decision
- Substantially Equivalent (SESE)
- Type
- Special 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 Quantix/Or Blood Flow Monitor; Flexible Probe with Optional Vessel Stabilizer cleared by the FDA?
Quantix/Or Blood Flow Monitor; Flexible Probe with Optional Vessel Stabilizer (K050088) received a 510(k) decision of Substantially Equivalent on February 8, 2005, 26 days after the submission was received.
What is the product code of K050088?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.