The following data is part of a premarket notification filed by Micronaire Corp. with the FDA for Micronaire Iso-hood Max 5uv.
| Device ID | K912142 |
| 510k Number | K912142 |
| Device Name: | MICRONAIRE ISO-HOOD MAX 5UV |
| Classification | Light, Operating, Dental |
| Applicant | MICRONAIRE CORP. 705 LAURENS RD. Greenville, SC 29607 |
| Contact | Nathanial E.cain |
| Correspondent | Nathanial E.cain MICRONAIRE CORP. 705 LAURENS RD. Greenville, SC 29607 |
| Product Code | EAZ |
| CFR Regulation Number | 872.4630 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-05-14 |
| Decision Date | 1991-10-30 |