The following data is part of a premarket notification filed by Parke-davis Co. with the FDA for Deseret Disposable Pressure Transducer.
Device ID | K841968 |
510k Number | K841968 |
Device Name: | DESERET DISPOSABLE PRESSURE TRANSDUCER |
Classification | Transducer, Blood-pressure, Extravascular |
Applicant | PARKE-DAVIS CO. 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 | 1984-05-15 |
Decision Date | 1984-08-06 |