The following data is part of a premarket notification filed by Waters Assoc., Inc. with the FDA for Calibrator, Dynamic.
Device ID | K781692 |
510k Number | K781692 |
Device Name: | CALIBRATOR, DYNAMIC |
Classification | Densitometer |
Applicant | WATERS ASSOC., INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | DXM |
CFR Regulation Number | 870.1450 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1978-10-04 |
Decision Date | 1978-11-29 |