FlowMet
Flowmeter, Blood, Cardiovascular
Laser Associated Sciences, Inc.
The following data is part of a premarket notification filed by Laser Associated Sciences, Inc. with the FDA for Flowmet.
Pre-market Notification Details
| Device ID | K192966 |
| 510k Number | K192966 |
| Device Name: | FlowMet |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | Laser Associated Sciences, Inc. 5171 California Ave., Suite 150 Irvine, CA 92617 |
| Contact | Sean White |
| Correspondent | Sean White Laser Associated Sciences, Inc. 5171 California Ave., Suite 150 Irvine, CA 92617 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-10-23 |
| Decision Date | 2020-01-10 |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001276138 | K192966 | 000 |
| 00860001276121 | K192966 | 000 |
| 10860001276111 | K192966 | 000 |
| 00763000502843 | K192966 | 000 |
Trademark Results [FlowMet]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 FLOWMET 88342522 5889436 Live/Registered |
Laser Associated Sciences, Inc. 2019-03-15 |
 FLOWMET 79276566 not registered Live/Pending |
Ascenz Pte Ltd 2019-11-13 |
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