The following data is part of a premarket notification filed by J. H. Emerson Co. with the FDA for Emerson Cough Assist Model Ca-3000 W/automatic Timing And Model Cm-3000 W/manual Timing.
| Device ID | K002598 |
| 510k Number | K002598 |
| Device Name: | EMERSON COUGH ASSIST MODEL CA-3000 W/AUTOMATIC TIMING AND MODEL CM-3000 W/MANUAL TIMING |
| Classification | Device, Positive Pressure Breathing, Intermittent |
| Applicant | J. H. EMERSON CO. 22 COTTAGE PARK AVE. Cambridge, MA 02140 -1691 |
| Contact | George Emerson |
| Correspondent | George 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 | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-21 |
| Decision Date | 2000-11-22 |