The following data is part of a premarket notification filed by Imatron, Inc. with the FDA for Universal Examination Table.
Device ID | K874934 |
510k Number | K874934 |
Device Name: | UNIVERSAL EXAMINATION TABLE |
Classification | Table, Radiologic |
Applicant | IMATRON, INC. 389 OYSTER POINT BLVD. South San Francisco, CA 94080 |
Contact | J. A Coduto |
Correspondent | J. A Coduto IMATRON, INC. 389 OYSTER POINT BLVD. South San Francisco, CA 94080 |
Product Code | KXJ |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1987-12-04 |
Decision Date | 1988-01-19 |