510(k) K864095
K864095 is an FDA 510(k) premarket notification submitted by Gambro, Inc. for the device "ENGSTROM EDITH MODELS 500,1000,1500 & 1500F". The FDA issued a decision of Substantially Equivalent on February 20, 1987. The device falls under product code BYD (Condenser, Heat And Moisture (Artificial Nose)), a Class I device regulated under 21 CFR 868.5375. Gambro, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 20, 1987
- Date Received
- October 21, 1986
- 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