510(k) K853154
K853154 is an FDA 510(k) premarket notification submitted by Robert Bosch Corp. for the device "HV-4". The FDA issued a decision of SN on March 28, 1986. The device falls under product code IPF (Stimulator, Muscle, Powered), a Class II device regulated under 21 CFR 890.5850. Robert Bosch Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SN ()
- Decision Date
- March 28, 1986
- Date Received
- July 29, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stimulator, Muscle, Powered
- Device Class
- Class II
- Regulation Number
- 890.5850
- Review Panel
- PM
- Submission Type