The following data is part of a premarket notification filed by Seattle Childrens Hospital with the FDA for Seattle - Pap.
| Device ID | K131502 |
| 510k Number | K131502 |
| Device Name: | SEATTLE - PAP |
| Classification | Ventilator, Non-continuous (respirator) |
| Applicant | SEATTLE CHILDRENS HOSPITAL 1900 NINTH AVENUE Seattle, WA 98101 |
| Contact | Paul Dryden |
| Correspondent | Paul Dryden SEATTLE CHILDRENS HOSPITAL 1900 NINTH AVENUE Seattle, WA 98101 |
| Product Code | BZD |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-05-24 |
| Decision Date | 2013-10-11 |
| Summary: | summary |