The following data is part of a premarket notification filed by American Pharmaseal Div. Ahsc with the FDA for Disposable Pressure Transducer.
Device ID | K830210 |
510k Number | K830210 |
Device Name: | DISPOSABLE PRESSURE TRANSDUCER |
Classification | Transducer, Blood-pressure, Extravascular |
Applicant | AMERICAN PHARMASEAL DIV. AHSC 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DRS |
CFR Regulation Number | 870.2850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-01-24 |
Decision Date | 1983-04-18 |