The following data is part of a premarket notification filed by Inspiron Corp. with the FDA for Inspiron I.m.v. Set Up.
| Device ID | K760891 |
| 510k Number | K760891 |
| Device Name: | INSPIRON I.M.V. SET UP |
| Classification | Attachment, Intermittent Mandatory Ventilation (imv) |
| Applicant | INSPIRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | CBO |
| CFR Regulation Number | 868.5955 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1976-10-26 |
| Decision Date | 1976-12-09 |