The following data is part of a premarket notification filed by Transonic Systems, Inc. with the FDA for Advance Laser Flowmeter, Alf 21.
| Device ID | K903633 |
| 510k Number | K903633 |
| Device Name: | ADVANCE LASER FLOWMETER, ALF 21 |
| Classification | Flowmeter, Blood, Cardiovascular |
| Applicant | TRANSONIC SYSTEMS, INC. WARREN RD. BUSINESS PARK 34 DUTCH MILL RD. Ithaca, NY 14850 |
| Contact | Cornelis J Drost |
| Correspondent | Cornelis J Drost TRANSONIC SYSTEMS, INC. WARREN RD. BUSINESS PARK 34 DUTCH MILL RD. Ithaca, NY 14850 |
| Product Code | DPW |
| CFR Regulation Number | 870.2100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-08-10 |
| Decision Date | 1990-10-09 |