510(k) K840250
K840250 is an FDA 510(k) premarket notification submitted by Convaid Products, Inc. for the device "CARRIER". The FDA issued a decision of Substantially Equivalent on February 9, 1984. The device falls under product code LBE (Stroller, Adaptive), a Class I device regulated under 21 CFR 890.3850. Convaid Products, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 9, 1984
- Date Received
- January 11, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stroller, Adaptive
- Device Class
- Class I
- Regulation Number
- 890.3850
- Review Panel
- PM
- Submission Type