The following data is part of a premarket notification filed by Pro-tech, Inc. with the FDA for Ez-1 System Respiratory Effort Sensors.
Device ID | K913395 |
510k Number | K913395 |
Device Name: | EZ-1 SYSTEM RESPIRATORY EFFORT SENSORS |
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 | 1992-05-20 |