The following data is part of a premarket notification filed by J. H. Emerson Co. with the FDA for Emerson 33-an Negative Pressure Respirator Alarm.
| Device ID | K902764 |
| 510k Number | K902764 |
| Device Name: | EMERSON 33-AN NEGATIVE PRESSURE RESPIRATOR ALARM |
| Classification | Ventilator, External Body, Negative Pressure, Adult (cuirass) |
| 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 | BYT |
| CFR Regulation Number | 868.5935 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1990-06-25 |
| Decision Date | 1990-11-19 |