The following data is part of a premarket notification filed by Laerdal Medical A/s with the FDA for Laerdal Paediatric Pocket Mask, Model 820050.
| Device ID | K023805 |
| 510k Number | K023805 |
| Device Name: | LAERDAL PAEDIATRIC POCKET MASK, MODEL 820050 |
| Classification | Valve, Non-rebreathing |
| Applicant | LAERDAL MEDICAL A/S TANKE SVILANDSGATE 30 Stavanger, NO 4002 |
| Contact | Magne Steinset |
| Correspondent | Magne Steinset LAERDAL MEDICAL A/S TANKE SVILANDSGATE 30 Stavanger, NO 4002 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2002-11-14 |
| Decision Date | 2003-02-11 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 07045432001433 | K023805 | 000 |
| 07045430078673 | K023805 | 000 |
| 07045430075559 | K023805 | 000 |
| 07045430011564 | K023805 | 000 |
| 07045430011557 | K023805 | 000 |