The following data is part of a premarket notification filed by Transamerica Delaval, Inc. with the FDA for Administration Set.
Device ID | K851988 |
510k Number | K851988 |
Device Name: | ADMINISTRATION SET |
Classification | Transducer, Blood-pressure, Extravascular |
Applicant | TRANSAMERICA DELAVAL, INC. 325 HALSTEAD ST. P.O. BIN 7087 Pasadena, CA 91109 |
Contact | Richard G Ekstrom |
Correspondent | Richard G Ekstrom TRANSAMERICA DELAVAL, INC. 325 HALSTEAD ST. P.O. BIN 7087 Pasadena, CA 91109 |
Product Code | DRS |
CFR Regulation Number | 870.2850 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1985-05-07 |
Decision Date | 1985-08-16 |