The following data is part of a premarket notification filed by Laser Associated Sciences, Inc. with the FDA for Flowmet-r.
| Device ID | K182494 |
| 510k Number | K182494 |
| Device Name: | FlowMet-R |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | Laser Associated Sciences, Inc. 16 Foxglove Way Irvine, CA 92612 |
| Contact | Sean White |
| Correspondent | Sean White Laser Associated Sciences, Inc. 16 Foxglove Way Irvine, CA 92612 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2018-09-11 |
| Decision Date | 2019-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00860001276107 | K182494 | 000 |