510(k) K935036
K935036 is an FDA 510(k) premarket notification submitted by Intertech Resources, Inc. for the device "HEPA FILTERED HEAT AND MOISTURE EXCHANGER". The FDA issued a decision of Substantially Equivalent (kit) on January 25, 1994. The device falls under product code BYD (Condenser, Heat And Moisture (Artificial Nose)), a Class I device regulated under 21 CFR 868.5375. Intertech Resources, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- January 25, 1994
- Date Received
- September 29, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Condenser, Heat And Moisture (Artificial Nose)
- Device Class
- Class I
- Regulation Number
- 868.5375
- Review Panel
- AN
- Submission Type