The following data is part of a premarket notification filed by Timeter Instrument Corp. with the FDA for Mo8 Oxygen Flowmeter.
| Device ID | K802311 |
| 510k Number | K802311 |
| Device Name: | MO8 OXYGEN FLOWMETER |
| Classification | Flowmeter, Tube, Thorpe, Back-pressure Compensated |
| Applicant | TIMETER INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CAX |
| CFR Regulation Number | 868.2340 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1980-09-23 |
| Decision Date | 1980-10-23 |