The following data is part of a premarket notification filed by Gentex Corporation with the FDA for Patient Isolation Unit, Model G019-1000.
| Device ID | K080117 |
| 510k Number | K080117 |
| Device Name: | PATIENT ISOLATION UNIT, MODEL G019-1000 |
| Classification | Chamber, Patient Isolation |
| Applicant | GENTEX CORPORATION 11525 SIXTH ST. Rancho Cucamonga, CA 91730 |
| Contact | Barry Shope |
| Correspondent | Barry Shope GENTEX CORPORATION 11525 SIXTH ST. Rancho Cucamonga, CA 91730 |
| Product Code | LGM |
| CFR Regulation Number | 880.5450 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-17 |
| Decision Date | 2009-01-30 |