The following data is part of a premarket notification filed by Westmed Intl. with the FDA for Westmed Pediatric And Adult Aerosol Mask.
| Device ID | K945472 |
| 510k Number | K945472 |
| Device Name: | WESTMED PEDIATRIC AND ADULT AEROSOL MASK |
| Classification | Mask, Oxygen |
| Applicant | WESTMED INTL. 3351 EAST HEMISPHERE LOOP Tucson, AZ 85706 |
| Contact | Lynn Hayse |
| Correspondent | Lynn Hayse WESTMED INTL. 3351 EAST HEMISPHERE LOOP Tucson, AZ 85706 |
| Product Code | BYG |
| CFR Regulation Number | 868.5580 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-11-08 |
| Decision Date | 1995-02-07 |