The following data is part of a premarket notification filed by Baylor Biomedical Services with the FDA for Environmental Control Unit Model 7000.
| Device ID | K901028 |
| 510k Number | K901028 |
| Device Name: | ENVIRONMENTAL CONTROL UNIT MODEL 7000 |
| Classification | System, Environmental Control, 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 | IQA |
| CFR Regulation Number | 890.3725 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-03-06 |
| Decision Date | 1990-03-13 |