The following data is part of a premarket notification filed by Abbott Medical Electronics Co. with the FDA for Preamplifier Module, Ekg Respiration.
| Device ID | K790304 |
| 510k Number | K790304 |
| Device Name: | PREAMPLIFIER MODULE, EKG RESPIRATION |
| Classification | Monitor, Breathing Frequency |
| Applicant | ABBOTT MEDICAL ELECTRONICS CO. Houston, TX |
| Product Code | BZQ |
| CFR Regulation Number | 868.2375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-02-13 |
| Decision Date | 1979-02-27 |