The following data is part of a premarket notification filed by Intensive Technology, Inc. with the FDA for Respa-trol.
| Device ID | K810107 | 
| 510k Number | K810107 | 
| Device Name: | RESPA-TROL | 
| Classification | Controls For Blood-gases, (assayed And Unassayed) | 
| Applicant | INTENSIVE TECHNOLOGY, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 | 
| Product Code | JJS | 
| CFR Regulation Number | 862.1660 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1981-01-16 | 
| Decision Date | 1981-01-26 | 
| Mark Image Registration | Serial | Company Trademark Application Date | 
|---|---|
|  RESPA-TROL  73317996  1240747 Dead/Cancelled | Intensive Technology, Inc. 1981-07-07 |