The following data is part of a premarket notification filed by Bio-medical Devices, Inc. with the FDA for Maxair Surgical Helmet System.
| Device ID | K040485 |
| 510k Number | K040485 |
| Device Name: | MAXAIR SURGICAL HELMET SYSTEM |
| Classification | Gown, Surgical |
| Applicant | BIO-MEDICAL DEVICES, INC. 17171 DAIMLER AVE. Irvine, CA 92614 |
| Contact | Nick Herbert |
| Correspondent | Nick Herbert BIO-MEDICAL DEVICES, INC. 17171 DAIMLER AVE. Irvine, CA 92614 |
| Product Code | FYA |
| CFR Regulation Number | 878.4040 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-02-25 |
| Decision Date | 2004-10-18 |
| Summary: | summary |