The following data is part of a premarket notification filed by Advanced Medical Equipment, Inc. with the FDA for Respiratory Care Monitor.
| Device ID | K812977 |
| 510k Number | K812977 |
| Device Name: | RESPIRATORY CARE MONITOR |
| Classification | Connector, Airway (extension) |
| Applicant | ADVANCED MEDICAL EQUIPMENT, INC. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZA |
| CFR Regulation Number | 868.5810 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1981-10-23 |
| Decision Date | 1981-11-16 |