The following data is part of a premarket notification filed by Impact Instrumentation, Inc. with the FDA for Respiratory Sensor (model 409 W/nasoph.).
Device ID | K811265 |
510k Number | K811265 |
Device Name: | RESPIRATORY SENSOR (MODEL 409 W/NASOPH.) |
Classification | Monitor, Breathing Frequency |
Applicant | IMPACT INSTRUMENTATION, INC. 4221 Richmond Rd., N.W. Walker, MI 49534 |
Product Code | BZQ |
CFR Regulation Number | 868.2375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-05-12 |
Decision Date | 1981-06-02 |