510(k) K954194
K954194 is an FDA 510(k) premarket notification submitted by Engstrom Medical for the device "DISPOSABLE HME/FILTER". The FDA issued a decision of Substantially Equivalent on October 20, 1995. The device falls under product code BYD (Condenser, Heat And Moisture (Artificial Nose)), a Class I device regulated under 21 CFR 868.5375. Engstrom Medical has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 20, 1995
- Date Received
- September 6, 1995
- 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