510(k) K832322
K832322 is an FDA 510(k) premarket notification submitted by Intl. Medical Equipment Corp. for the device "BASE ONLY, TORONTO CHAIR". The FDA issued a decision of Substantially Equivalent on August 12, 1983. The device falls under product code IQC (Wheelchair, Special Grade), a Class II device regulated under 21 CFR 890.3880. Intl. Medical Equipment Corp. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 1983
- Date Received
- July 15, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wheelchair, Special Grade
- Device Class
- Class II
- Regulation Number
- 890.3880
- Review Panel
- PM
- Submission Type