The following data is part of a premarket notification filed by Laerdal Medical Corp. with the FDA for Resusci Patient Face Shield.
| Device ID | K880450 |
| 510k Number | K880450 |
| Device Name: | RESUSCI PATIENT FACE SHIELD |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | LAERDAL MEDICAL CORP. P.O. BOX 190, ONE LABRIOLA CT. Armonk, NY 10504 |
| Contact | Ronald L Weyhrauch |
| Correspondent | Ronald L Weyhrauch LAERDAL MEDICAL CORP. P.O. BOX 190, ONE LABRIOLA CT. Armonk, NY 10504 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-02-02 |
| Decision Date | 1988-03-04 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07045432068665 | K880450 | 000 |
| 07045430040472 | K880450 | 000 |
| 07045430040502 | K880450 | 000 |
| 07045430040670 | K880450 | 000 |
| 07045431500197 | K880450 | 000 |
| 07045431500203 | K880450 | 000 |
| 07045431500210 | K880450 | 000 |
| 07045431500371 | K880450 | 000 |
| 07045432068535 | K880450 | 000 |
| 07045432068573 | K880450 | 000 |
| 07045432068580 | K880450 | 000 |
| 07045432068597 | K880450 | 000 |
| 07045432068603 | K880450 | 000 |
| 07045430040465 | K880450 | 000 |