510(k) K884019
K884019 is an FDA 510(k) premarket notification submitted by Alm Surgical Equipment, Inc. for the device "ALM OPERATING TABLES". The FDA issued a decision of Substantially Equivalent on October 13, 1988. The device falls under product code FWX (Table, Operating-Room, Mechanical), a Class I device regulated under 21 CFR 878.4950. Alm Surgical Equipment, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 13, 1988
- Date Received
- September 22, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Operating-Room, Mechanical
- Device Class
- Class I
- Regulation Number
- 878.4950
- Review Panel
- SU
- Submission Type