510(k) K770438
K770438 is an FDA 510(k) premarket notification submitted by I E Industries for the device "CART, PROCEDURES". The FDA issued a decision of Substantially Equivalent on July 1, 1977. The device falls under product code HDD (Table, Obstetrical, Ac-Powered (And Accessories)), a Class II device regulated under 21 CFR 884.4900. I E Industries has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 1, 1977
- Date Received
- March 7, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Obstetrical, Ac-Powered (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.4900
- Review Panel
- OB
- Submission Type