The following data is part of a premarket notification filed by Oec-diasonics, Inc. with the FDA for F.a.s.t. Table.
Device ID | K896583 |
510k Number | K896583 |
Device Name: | F.A.S.T. TABLE |
Classification | Table, Radiographic, Tilting |
Applicant | OEC-DIASONICS, INC. 384 WRIGHT BROTHERS DR. Salt Lake City, UT 84116 |
Contact | John W Tolhurst |
Correspondent | John W Tolhurst OEC-DIASONICS, INC. 384 WRIGHT BROTHERS DR. Salt Lake City, UT 84116 |
Product Code | IXR |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-11-21 |
Decision Date | 1990-03-01 |