510(k) K871435
K871435 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "BARD EMS SYSTEM 6000 E.S.U.". The FDA issued a decision of Substantially Equivalent on May 11, 1987. The device falls under product code HAM (Apparatus, Electrosurgical), a Class II device regulated under 21 CFR 878.4400. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 11, 1987
- Date Received
- April 13, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Electrosurgical
- Device Class
- Class II
- Regulation Number
- 878.4400
- Review Panel
- SU
- Submission Type