The following data is part of a premarket notification filed by Med-tron Products, Inc. with the FDA for Med-tron Spect Imaging Table.
Device ID | K952701 |
510k Number | K952701 |
Device Name: | MED-TRON SPECT IMAGING TABLE |
Classification | Table, Radiographic, Non-tilting, Powered |
Applicant | MED-TRON PRODUCTS, INC. 600 D NORTH BICYCLE PATH Port Jefferson Sta., NY 11776 |
Contact | Lawrence Bonitch |
Correspondent | Lawrence Bonitch MED-TRON PRODUCTS, INC. 600 D NORTH BICYCLE PATH Port Jefferson Sta., NY 11776 |
Product Code | IZZ |
CFR Regulation Number | 892.1980 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-06-13 |
Decision Date | 1995-07-06 |