The following data is part of a premarket notification filed by Pro-tech Services, Inc. with the FDA for Adam Shell Thermocouple Assembly.
| Device ID | K944175 |
| 510k Number | K944175 |
| Device Name: | ADAM SHELL THERMOCOUPLE ASSEMBLY |
| Classification | Spirometer, Diagnostic |
| Applicant | PRO-TECH SERVICES, INC. 17710-134TH AVE N.E. P.O BOX 2165 Woodinville, WA 98072 |
| Contact | Randy Carruthers |
| Correspondent | Randy Carruthers PRO-TECH SERVICES, INC. 17710-134TH AVE N.E. P.O BOX 2165 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 | 1994-08-26 |
| Decision Date | 1994-10-14 |