The following data is part of a premarket notification filed by J. H. Emerson Co. with the FDA for Negative Pressure Chest Respirator Pump.
| Device ID | K832176 |
| 510k Number | K832176 |
| Device Name: | NEGATIVE PRESSURE CHEST RESPIRATOR PUMP |
| Classification | Ventilator, External Body, Negative Pressure, Adult (cuirass) |
| Applicant | J. H. EMERSON CO. 4221 Richmond Rd., N.W. Walker, MI 49534 |
| Product Code | BYT |
| CFR Regulation Number | 868.5935 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-07-06 |
| Decision Date | 1983-09-12 |