The following data is part of a premarket notification filed by Westmed, Inc. with the FDA for Westmed Pediatric & Adult Medium Concentration Oxygen Mask.
| Device ID | K953464 |
| 510k Number | K953464 |
| Device Name: | WESTMED PEDIATRIC & ADULT MEDIUM CONCENTRATION OXYGEN MASK |
| Classification | Mask, Oxygen |
| Applicant | Westmed, Inc. 3351 EAST HEMISPHERE LOOP Tucson, AZ 85706 |
| Contact | Mr. Lynn Hayse |
| Correspondent | Mr. Lynn Hayse Westmed, Inc. 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 | 1995-07-24 |
| Decision Date | 1995-09-18 |