510(k) K182494
K182494 is an FDA 510(k) premarket notification submitted by Laser Associated Sciences, Inc. for the device "FlowMet-R". The FDA issued a decision of Substantially Equivalent on February 27, 2019. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Laser Associated Sciences, Inc. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 27, 2019
- Date Received
- September 11, 2018
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Flowmeter, Blood, Cardiovascular
- Device Class
- Class II
- Regulation Number
- 870.2100
- Review Panel
- CV
- Submission Type