510(k) K954278
K954278 is an FDA 510(k) premarket notification submitted by Beta Medical Products, Inc. for the device "BETA MULTI-PROCEDURE MOBILE UROLOGICAL TABLE, MODEL S5005". The FDA issued a decision of Substantially Equivalent on October 2, 1995. The device falls under product code MMZ (Table, Cystometric, Electric), a Class II device regulated under 21 CFR 876.4890. Beta Medical Products, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 2, 1995
- Date Received
- September 13, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Cystometric, Electric
- Device Class
- Class II
- Regulation Number
- 876.4890
- Review Panel
- GU
- Submission Type