The following data is part of a premarket notification filed by Resmed Ltd. with the FDA for Vpap St.
| Device ID | K080131 |
| 510k Number | K080131 |
| Device Name: | VPAP ST |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | RESMED LTD. 14040 DANIELSON ST. Poway, CA 92064 -6857 |
| Contact | David D'cruz |
| Correspondent | David D'cruz RESMED LTD. 14040 DANIELSON ST. Poway, CA 92064 -6857 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2008-01-18 |
| Decision Date | 2008-04-01 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00619498269600 | K080131 | 000 |
| 00619498269587 | K080131 | 000 |
| 00619498269556 | K080131 | 000 |
| 00619498269549 | K080131 | 000 |
| 00619498269532 | K080131 | 000 |
| 00619498269525 | K080131 | 000 |
| 00619498249275 | K080131 | 000 |