The following data is part of a premarket notification filed by Baylor Biomedical Services with the FDA for Rotary Communication Scanner Model 7010.
Device ID | K901030 |
510k Number | K901030 |
Device Name: | ROTARY COMMUNICATION SCANNER MODEL 7010 |
Classification | System, Communication, Powered |
Applicant | BAYLOR BIOMEDICAL SERVICES 3707 GASTON AVE., #216 Dallas, TX 75246 |
Contact | Jeff Butler |
Correspondent | Jeff Butler BAYLOR BIOMEDICAL SERVICES 3707 GASTON AVE., #216 Dallas, TX 75246 |
Product Code | ILQ |
CFR Regulation Number | 890.3710 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1990-03-06 |
Decision Date | 1990-03-13 |