The following data is part of a premarket notification filed by J. H. Emerson Co. with the FDA for Emerson In-exsufflator, Models 2-cm & 2-ca.
| Device ID | K924174 |
| 510k Number | K924174 |
| Device Name: | EMERSON IN-EXSUFFLATOR, MODELS 2-CM & 2-CA |
| Classification | Device, Positive Pressure Breathing, Intermittent |
| Applicant | J. H. EMERSON CO. 22 COTTAGE PARK AVE. Cambridge, MA 02140 -1691 |
| Contact | George P Emerson |
| Correspondent | George P Emerson J. H. EMERSON CO. 22 COTTAGE PARK AVE. Cambridge, MA 02140 -1691 |
| Product Code | NHJ |
| CFR Regulation Number | 868.5905 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-08-19 |
| Decision Date | 1992-11-17 |