The following data is part of a premarket notification filed by Pro-tech, Inc. with the FDA for Cannula Style Thermocouples.
| Device ID | K913396 |
| 510k Number | K913396 |
| Device Name: | CANNULA STYLE THERMOCOUPLES |
| Classification | Spirometer, Diagnostic |
| 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 | BZG |
| CFR Regulation Number | 868.1840 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-07-30 |
| Decision Date | 1992-05-22 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00606959010314 | K913396 | 000 |
| 00606959010079 | K913396 | 000 |
| 00606959009998 | K913396 | 000 |
| 00606959009981 | K913396 | 000 |
| 00606959009974 | K913396 | 000 |
| 00606959007239 | K913396 | 000 |
| 30606959037206 | K913396 | 000 |
| 00606959037199 | K913396 | 000 |