510(k) K770086
K770086 is an FDA 510(k) premarket notification submitted by Health Improvement Assoc. for the device "SANAR". The FDA issued a decision of Substantially Equivalent on April 18, 1977. The device falls under product code IMB (Cabinet, Moist Steam), a Class II device regulated under 21 CFR 890.5250. Health Improvement Assoc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 18, 1977
- Date Received
- January 14, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cabinet, Moist Steam
- Device Class
- Class II
- Regulation Number
- 890.5250
- Review Panel
- PM
- Submission Type