The following data is part of a premarket notification filed by Westmed Intl. with the FDA for Westmed Respiratory Luer Adaptor.
| Device ID | K953506 |
| 510k Number | K953506 |
| Device Name: | WESTMED RESPIRATORY LUER ADAPTOR |
| Classification | Flowmeter, Calibration, Gas |
| Applicant | WESTMED INTL. 3351 EAST HEMISPHERE LOOP Tucson, AZ 85706 |
| Contact | Lynn D Hayse |
| Correspondent | Lynn D Hayse WESTMED INTL. 3351 EAST HEMISPHERE LOOP Tucson, AZ 85706 |
| Product Code | BXY |
| CFR Regulation Number | 868.2350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-07-26 |
| Decision Date | 1995-09-15 |