The following data is part of a premarket notification filed by Laerdal Medical Corp. with the FDA for Laerdal Pocket Mask.
| Device ID | K861401 |
| 510k Number | K861401 |
| Device Name: | LAERDAL POCKET MASK |
| Classification | Valve, Non-rebreathing |
| 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 | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1986-04-15 |
| Decision Date | 1986-05-21 |