510(k) K874688
K874688 is an FDA 510(k) premarket notification submitted by Huntleigh Technology, Inc. for the device "FLOWTRON AC200/2". The FDA issued a decision of Substantially Equivalent on September 23, 1988. The device falls under product code IRP (Massager, Powered Inflatable Tube), a Class II device regulated under 21 CFR 890.5650. Huntleigh Technology, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 23, 1988
- Date Received
- November 13, 1987
- 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