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 |