The following data is part of a premarket notification filed by Medix Medical Electronics (u.s.a.), Inc. with the FDA for Infant Apnea Monitor Model 100.
| Device ID | K812045 |
| 510k Number | K812045 |
| Device Name: | INFANT APNEA MONITOR MODEL 100 |
| Classification | Monitor, Breathing Frequency |
| Applicant | MEDIX MEDICAL ELECTRONICS (U.S.A.), 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 | 1981-07-21 |
| Decision Date | 1981-09-24 |