The following data is part of a premarket notification filed by Physicians Digital Co. with the FDA for Kronamax Kube.
Device ID | K893903 |
510k Number | K893903 |
Device Name: | KRONAMAX KUBE |
Classification | Goniometer, Ac-powered |
Applicant | PHYSICIANS DIGITAL CO. 12600 SAN PABLO AVE. SUITE A Richmond, CA 94805 |
Contact | David R Schultz |
Correspondent | David R Schultz PHYSICIANS DIGITAL CO. 12600 SAN PABLO AVE. SUITE A Richmond, CA 94805 |
Product Code | KQX |
CFR Regulation Number | 888.1500 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1989-05-30 |
Decision Date | 1989-11-29 |