FlowMet-R
FDA 510(k) K182494 · Laser Associated Sciences, Inc.
510(k) numberK182494
Submission
- Device name
- FlowMet-R
- Applicant
- Laser Associated Sciences, Inc.
Irvine, CA, US - Received
- September 11, 2018
- Decision date
- February 27, 2019
- 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 |
|---|---|---|
| K192966 | FlowMetDPW · Special | 01/10/2020SE |
Questions and answers
When was FlowMet-R cleared by the FDA?
FlowMet-R (K182494) received a 510(k) decision of Substantially Equivalent on February 27, 2019, 169 days after the submission was received.
What is the product code of K182494?
The FDA product code is DPW – Flowmeter, Blood, Cardiovascular, a Class II (moderate risk) device regulated under 21 CFR 870.2100.