The following data is part of a premarket notification filed by Transonic Systems, Inc. with the FDA for Transonic Flowmeter.
Device ID | K872048 |
510k Number | K872048 |
Device Name: | TRANSONIC FLOWMETER |
Classification | Flowmeter, Blood, Cardiovascular |
Applicant | TRANSONIC SYSTEMS, INC. CORNELL RESEARCH PARK 138 LANGMUIR LABS Ithaca, NY 14850 |
Contact | Shawn P Creighton |
Correspondent | Shawn P Creighton TRANSONIC SYSTEMS, INC. CORNELL RESEARCH PARK 138 LANGMUIR LABS 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 | 1987-05-28 |
Decision Date | 1988-06-21 |