510(k) K963091
K963091 is an FDA 510(k) premarket notification submitted by Hill-Rom, Inc. for the device "VOLLMAN PRONE POSITIONER". The FDA issued a decision of Substantially Equivalent on January 9, 1997. The device falls under product code IPT (Orthosis, Thoracic), a Class I device regulated under 21 CFR 890.3490. Hill-Rom, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 9, 1997
- Date Received
- August 8, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Orthosis, Thoracic
- Device Class
- Class I
- Regulation Number
- 890.3490
- Review Panel
- PM
- Submission Type