The following data is part of a premarket notification filed by Concord/portex with the FDA for Heat Moisture Condenser.
Device ID | K923910 |
510k Number | K923910 |
Device Name: | HEAT MOISTURE CONDENSER |
Classification | Condenser, Heat And Moisture (artificial Nose) |
Applicant | CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
Contact | Robert Wheeler |
Correspondent | Robert Wheeler CONCORD/PORTEX 15 KITT ST. Keene, NH 03431 |
Product Code | BYD |
CFR Regulation Number | 868.5375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1992-08-04 |
Decision Date | 1993-01-26 |