The following data is part of a premarket notification filed by Bsd Medical Corp. with the FDA for Bsd-200.
Device ID | K833158 |
510k Number | K833158 |
Device Name: | BSD-200 |
Classification | Thermometer, Electronic, Clinical |
Applicant | BSD MEDICAL CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | FLL |
CFR Regulation Number | 880.2910 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1983-09-16 |
Decision Date | 1984-03-30 |