510(k) K894134
K894134 is an FDA 510(k) premarket notification submitted by Midmark Corp. for the device "POWER EXAMINATION TABLE MODEL # 411". The FDA issued a decision of Substantially Equivalent on August 28, 1989. The device falls under product code LGX (Table, Examination, Medical, Powered), a Class I device regulated under 21 CFR 878.4960. Midmark Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 28, 1989
- Date Received
- June 13, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Examination, Medical, Powered
- Device Class
- Class I
- Regulation Number
- 878.4960
- Review Panel
- HO
- Submission Type