The following data is part of a premarket notification filed by Inspiron Corp. with the FDA for Vol. Ventilator Setup W/out Nebulizer.
| Device ID | K772069 |
| 510k Number | K772069 |
| Device Name: | VOL. VENTILATOR SETUP W/OUT NEBULIZER |
| Classification | Set, Tubing And Support, Ventilator (w Harness) |
| Applicant | INSPIRON CORP. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BZO |
| CFR Regulation Number | 868.5975 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1977-11-01 |
| Decision Date | 1977-11-15 |