The following data is part of a premarket notification filed by Timeter Instrument Corp. with the FDA for Datascribe #ds-40.
| Device ID | K812765 |
| 510k Number | K812765 |
| Device Name: | DATASCRIBE #DS-40 |
| Classification | Calibrator, Volume, Gas |
| Applicant | TIMETER INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BXW |
| CFR Regulation Number | 868.1870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-05 |
| Decision Date | 1981-11-16 |