510(k) K800526
K800526 is an FDA 510(k) premarket notification submitted by Surgical Mechanical Research, Inc. for the device "SMR H-CHAIR". The FDA issued a decision of Substantially Equivalent on March 18, 1980. The device falls under product code ETF (Unit, Examining/Treatment, Ent), a Class I device regulated under 21 CFR 874.5300. Surgical Mechanical Research, Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 18, 1980
- Date Received
- March 7, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Unit, Examining/Treatment, Ent
- Device Class
- Class I
- Regulation Number
- 874.5300
- Review Panel
- EN
- Submission Type