510(k) K994057
K994057 is an FDA 510(k) premarket notification submitted by Medical Compression Systems (Dbn) , Ltd. for the device "SLENDAIR 4000 COMPRESSION SYSTEM". The FDA issued a decision of Substantially Equivalent on Mar 3, 2000. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Medical Compression Systems (Dbn) , Ltd. has 9 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Mar 3, 2000
- Date Received
- Nov 30, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Massager, Powered Inflatable Tube
- Device Class
- Class II
- Regulation Number
- 890.5650
- Review Panel
- PM
- Submission Type
- 510(k)