The following data is part of a premarket notification filed by Engineered Medical Systems with the FDA for Swivel Elbow.
| Device ID | K000215 |
| 510k Number | K000215 |
| Device Name: | SWIVEL ELBOW |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | ENGINEERED MEDICAL SYSTEMS 2055 EXECUTIVE DR. Indianapolis, IN 46241 |
| Contact | Bonnie Holly |
| Correspondent | Bonnie Holly ENGINEERED MEDICAL SYSTEMS 2055 EXECUTIVE DR. Indianapolis, IN 46241 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-01-24 |
| Decision Date | 2000-05-26 |