510(k) K192966
K192966 is an FDA 510(k) premarket notification submitted by Laser Associated Sciences, Inc. for the device "FlowMet". The FDA issued a decision of Substantially Equivalent on January 10, 2020. 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
- January 10, 2020
- Date Received
- October 23, 2019
- Clearance Type
- Special
- 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