The following data is part of a premarket notification filed by Advantech with the FDA for R-150-et Collimator.
Device ID | K896486 |
510k Number | K896486 |
Device Name: | R-150-ET COLLIMATOR |
Classification | Collimator, Manual, Radiographic |
Applicant | ADVANTECH 16 LAWRENCE ST. Wakefield, MA 01880 |
Contact | Charles E Moreland |
Correspondent | Charles E Moreland ADVANTECH 16 LAWRENCE ST. Wakefield, MA 01880 |
Product Code | IZX |
CFR Regulation Number | 892.1610 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-13 |
Decision Date | 1990-01-23 |