The following data is part of a premarket notification filed by Canon U.s.a., Inc. with the FDA for Canon Laser Blood Flowmeter (clbf) Model 100.
| Device ID | K992606 |
| 510k Number | K992606 |
| Device Name: | CANON LASER BLOOD FLOWMETER (CLBF) MODEL 100 |
| Classification | Ophthalmoscope, Ac-powered |
| Applicant | CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
| Contact | Ken Shadoff |
| Correspondent | Ken Shadoff CANON U.S.A., INC. ONE CANON PLAZA Lake Success, NY 11042 -1198 |
| Product Code | HLI |
| CFR Regulation Number | 886.1570 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-08-03 |
| Decision Date | 2000-06-21 |
| Summary: | summary |