The following data is part of a premarket notification filed by Atomic Products Corp. with the FDA for Spect Table, Model #056-760.
Device ID | K915541 |
510k Number | K915541 |
Device Name: | SPECT TABLE, MODEL #056-760 |
Classification | Bed, Scanning, Nuclear |
Applicant | ATOMIC PRODUCTS CORP. P.O. DRAWER R Shirley, NY 11967 |
Contact | Clyde Schlein |
Correspondent | Clyde Schlein ATOMIC PRODUCTS CORP. P.O. DRAWER R Shirley, NY 11967 |
Product Code | IYZ |
CFR Regulation Number | 892.1350 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1991-12-10 |
Decision Date | 1992-01-17 |