510(k) K862957
K862957 is an FDA 510(k) premarket notification submitted by Global Medical Prods, Inc. for the device "MERIVAARA GERIATRIC CHAIR MODEL 455". The FDA issued a decision of Substantially Equivalent on August 21, 1986. The device falls under product code INN (Chair, Adjustable, Mechanical), a Class I device regulated under 21 CFR 890.3100. Global Medical Prods, Inc. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 1986
- Date Received
- August 6, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Chair, Adjustable, Mechanical
- Device Class
- Class I
- Regulation Number
- 890.3100
- Review Panel
- PM
- Submission Type