The following data is part of a premarket notification filed by Pfizer, Inc. with the FDA for Diag. Console, Independent.
Device ID | K772291 |
510k Number | K772291 |
Device Name: | DIAG. CONSOLE, INDEPENDENT |
Classification | System, X-ray, Tomography, Computed |
Applicant | PFIZER, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | JAK |
CFR Regulation Number | 892.1750 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1977-12-12 |
Decision Date | 1977-12-21 |