510(k) K944194
K944194 is an FDA 510(k) premarket notification submitted by Med-Tek Innovations, Inc. for the device "DISPOSABLE HEAT & MOSITURE EXCHANGER & FILTER/HME". The FDA issued a decision of Substantially Equivalent on September 13, 1994. The device falls under product code BYD (Condenser, Heat And Moisture (Artificial Nose)), a Class I device regulated under 21 CFR 868.5375. Med-Tek Innovations, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 13, 1994
- Date Received
- August 29, 1994
- 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