510(k) K823151
K823151 is an FDA 510(k) premarket notification submitted by Orthion Corp. for the device "OB TRIPP TRANSPORT CHAIR". The FDA issued a decision of Substantially Equivalent on November 5, 1982. The device falls under product code INM (Chair, With Casters), a Class I device regulated under 21 CFR 890.3100. Orthion Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 5, 1982
- Date Received
- October 20, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chair, With Casters
- Device Class
- Class I
- Regulation Number
- 890.3100
- Review Panel
- PM
- Submission Type