The following data is part of a premarket notification filed by Timeter Instrument Corp. with the FDA for Timeter Produced Purritan Bennett O2 Adp.
| Device ID | K801514 | 
| 510k Number | K801514 | 
| Device Name: | TIMETER PRODUCED PURRITAN BENNETT O2 ADP | 
| Classification | Tubing, Pressure And Accessories | 
| Applicant | TIMETER INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 | 
| Product Code | BYX | 
| CFR Regulation Number | 868.5860 [🔎] | 
| Decision | Substantially Equivalent (SESE) | 
| Type | Traditional | 
| 3rd Party Reviewed | No | 
| Combination Product | No | 
| Date Received | 1980-06-30 | 
| Decision Date | 1980-07-14 |