The following data is part of a premarket notification filed by Pro-tech, Inc. with the FDA for Crystal Trace Piezo Respiratory Effort Sensor.
| Device ID | K923402 |
| 510k Number | K923402 |
| Device Name: | CRYSTAL TRACE PIEZO RESPIRATORY EFFORT SENSOR |
| Classification | Monitor, Breathing Frequency |
| Applicant | PRO-TECH, INC. P.O. BOX 2165 17710-134TH AVENUE N.E. Woodinville, WA 98072 |
| Contact | Randy Carruthers |
| Correspondent | Randy Carruthers PRO-TECH, INC. P.O. BOX 2165 17710-134TH AVENUE N.E. Woodinville, WA 98072 |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-07-10 |
| Decision Date | 1992-12-30 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959011021 | K923402 | 000 |
| 00606959010772 | K923402 | 000 |
| 00606959010765 | K923402 | 000 |
| 00606959010758 | K923402 | 000 |
| 00606959007222 | K923402 | 000 |
| 00606959007215 | K923402 | 000 |
| 00606959038912 | K923402 | 000 |
| 00606959038905 | K923402 | 000 |
| 00606959038899 | K923402 | 000 |
| 00606959038882 | K923402 | 000 |
| 00606959038806 | K923402 | 000 |
| 00606959038790 | K923402 | 000 |
| 00606959029187 | K923402 | 000 |
| 00606959029170 | K923402 | 000 |
| 00606959010789 | K923402 | 000 |
| 00606959010796 | K923402 | 000 |
| 00606959010802 | K923402 | 000 |
| 00606959011014 | K923402 | 000 |
| 00606959011007 | K923402 | 000 |
| 00606959010956 | K923402 | 000 |
| 00606959010949 | K923402 | 000 |
| 00606959010925 | K923402 | 000 |
| 00606959010901 | K923402 | 000 |
| 00606959010895 | K923402 | 000 |
| 00606959010888 | K923402 | 000 |
| 00606959010871 | K923402 | 000 |
| 00606959010840 | K923402 | 000 |
| 00606959010833 | K923402 | 000 |
| 00606959010826 | K923402 | 000 |
| 00606959010819 | K923402 | 000 |
| 00606959027091 | K923402 | 000 |