The following data is part of a premarket notification filed by J. H. Emerson Co. with the FDA for Samson's Newborn Lung Inflator 340-1000.
| Device ID | K842487 |
| 510k Number | K842487 |
| Device Name: | SAMSON'S NEWBORN LUNG INFLATOR 340-1000 |
| Classification | Ventilator, Emergency, Manual (resuscitator) |
| Applicant | J. H. EMERSON CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BTM |
| CFR Regulation Number | 868.5915 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-06-26 |
| Decision Date | 1984-07-06 |