The following data is part of a premarket notification filed by Electronics For Medicine, Inc. with the FDA for Respiration/apnea Amplifier Model 3105.
| Device ID | K792528 |
| 510k Number | K792528 |
| Device Name: | RESPIRATION/APNEA AMPLIFIER MODEL 3105 |
| Classification | Monitor, Breathing Frequency |
| Applicant | ELECTRONICS FOR MEDICINE, 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 | 1979-12-07 |
| Decision Date | 1980-02-21 |