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 |