510(k) K903519
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 1990
- Date Received
- August 3, 1990
- 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