The following data is part of a premarket notification filed by Westmed Intl. with the FDA for Westmed Condesate Collection Trap.
| Device ID | K954271 |
| 510k Number | K954271 |
| Device Name: | WESTMED CONDESATE COLLECTION TRAP |
| Classification | Generator, Oxygen, Portable |
| Applicant | WESTMED INTL. 3351 EAST HEMISPHERE LOOP Tucson, AZ 85706 |
| Contact | Lynn D Hayre |
| Correspondent | Lynn D Hayre WESTMED INTL. 3351 EAST HEMISPHERE LOOP Tucson, AZ 85706 |
| Product Code | CAW |
| CFR Regulation Number | 868.5440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1995-09-12 |
| Decision Date | 1995-12-28 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 10709078005944 | K954271 | 000 |
| 00709078002601 | K954271 | 000 |
| 00709078002212 | K954271 | 000 |