510(k) K831309
K831309 is an FDA 510(k) premarket notification submitted by Amsco Co. for the device "DELIVERY 4 TABLE". The FDA issued a decision of Substantially Equivalent on June 15, 1983. The device falls under product code KNC (Table, Obstetric (And Accessories)), a Class II device regulated under 21 CFR 884.4900. Amsco Co. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 15, 1983
- Date Received
- April 22, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Obstetric (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.4900
- Review Panel
- OB
- Submission Type