The following data is part of a premarket notification filed by Intertech Resources, Inc. with the FDA for Heat & Moisture Exchanger.
Device ID | K955008 |
510k Number | K955008 |
Device Name: | HEAT & MOISTURE EXCHANGER |
Classification | Condenser, Heat And Moisture (artificial Nose) |
Applicant | INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
Contact | Avia Toney |
Correspondent | Avia Toney INTERTECH RESOURCES, INC. 5100 TICE ST. Ft. Myers, FL 33905 |
Product Code | BYD |
CFR Regulation Number | 868.5375 [🔎] |
Decision | Substantially Equivalent (SESE) |
Type | Traditional |
3rd Party Reviewed | No |
Combination Product | No |
Date Received | 1995-11-01 |
Decision Date | 1996-01-30 |