510(k) K943497
K943497 is an FDA 510(k) premarket notification submitted by Burke Neutech, Inc. for the device "CONTRAST 7000 THERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on Jun 7, 1995. The device falls under product code ILO (Pack, Hot Or Cold, Water Circulating), a Class II device regulated under 21 CFR 890.5720. Burke Neutech, Inc. has 6 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jun 7, 1995
- Date Received
- Jul 19, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Pack, Hot Or Cold, Water Circulating
- Device Class
- Class II
- Regulation Number
- 890.5720
- Review Panel
- PM
- Submission Type
- 510(k) Exempt