The following data is part of a premarket notification filed by Timeter Instrument Corp. with the FDA for Timeter Produced Ohio Oxygen Adaptor.
| Device ID | K811551 |
| 510k Number | K811551 |
| Device Name: | TIMETER PRODUCED OHIO OXYGEN ADAPTOR |
| Classification | Tubing, Pressure And Accessories |
| Applicant | TIMETER INSTRUMENT CORP. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BYX |
| CFR Regulation Number | 868.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-06-02 |
| Decision Date | 1981-06-18 |