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 |