The following data is part of a premarket notification filed by Timeter Instrument Corp. with the FDA for Pressure, Low/high Model C1070.
| Device ID | K781697 |
| 510k Number | K781697 |
| Device Name: | PRESSURE, LOW/HIGH MODEL C1070 |
| Classification | Monitor, Airway Pressure (includes Gauge And/or Alarm) |
| Applicant | TIMETER INSTRUMENT CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CAP |
| CFR Regulation Number | 868.2600 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1978-10-10 |
| Decision Date | 1978-10-27 |