The following data is part of a premarket notification filed by Impact Instrumentation, Inc. with the FDA for Respiratory Sensor.
Device ID | K811014 |
510k Number | K811014 |
Device Name: | RESPIRATORY SENSOR |
Classification | Monitor, Breathing Frequency |
Applicant | IMPACT INSTRUMENTATION, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
Product Code | BZQ |
CFR Regulation Number | 868.2375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1981-04-15 |
Decision Date | 1981-06-02 |