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 |