The following data is part of a premarket notification filed by Laerdal Medical Corp. with the FDA for Resusci Inflate-a-shield Cpr Barrier.
| Device ID | K001742 |
| 510k Number | K001742 |
| Device Name: | RESUSCI INFLATE-A-SHIELD CPR BARRIER |
| Classification | Valve, Non-rebreathing |
| Applicant | LAERDAL MEDICAL CORP. 49 PLAIN ST. North Attleboro, MA 02760 |
| Contact | Cynthia J Nolte |
| Correspondent | Cynthia J Nolte LAERDAL MEDICAL CORP. 49 PLAIN ST. North Attleboro, MA 02760 |
| Product Code | CBP |
| CFR Regulation Number | 868.5870 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-06-08 |
| Decision Date | 2000-10-06 |