The following data is part of a premarket notification filed by Portex, Inc. with the FDA for Thermovent 600, 1200, T, 02.
| Device ID | K874597 |
| 510k Number | K874597 |
| Device Name: | THERMOVENT 600, 1200, T, 02 |
| Classification | Condenser, Heat And Moisture (artificial Nose) |
| Applicant | PORTEX, INC. 42 INDUSTRIAL WAY Wilmington, MA 01887 |
| Contact | Edwin G Grove |
| Correspondent | Edwin G Grove PORTEX, INC. 42 INDUSTRIAL WAY Wilmington, MA 01887 |
| Product Code | BYD |
| CFR Regulation Number | 868.5375 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-09 |
| Decision Date | 1988-01-19 |