The following data is part of a premarket notification filed by Timeter Instrument Corp. with the FDA for Criterion I.
| Device ID | K834274 |
| 510k Number | K834274 |
| Device Name: | CRITERION I |
| Classification | Generator, Oxygen, Portable |
| Applicant | TIMETER INSTRUMENT CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-12-08 |
| Decision Date | 1984-04-13 |
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
![]() CRITERION I 81003090 1003090 Dead/Cancelled |
Royal Castle Systems, Inc. 0000-00-00 |