The following data is part of a premarket notification filed by Porta-lung Co. with the FDA for Ventilator External Body Negative Press.
| Device ID | K841090 |
| 510k Number | K841090 |
| Device Name: | VENTILATOR EXTERNAL BODY NEGATIVE PRESS |
| Classification | Ventilator, External Body, Negative Pressure, Adult (cuirass) |
| Applicant | PORTA-LUNG CO. 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | BYT |
| CFR Regulation Number | 868.5935 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-03-13 |
| Decision Date | 1984-05-30 |