510(k) K932149
K932149 is an FDA 510(k) premarket notification submitted by Thought Technology , Ltd. for the device "THOUGHT TECHNOLOGY VAGINAL & RECTAL ELECTRODE". The FDA issued a decision of Substantially Equivalent on May 11, 1995. The device falls under product code HIR (Perineometer), a Class II device regulated under 21 CFR 884.1425. Thought Technology , Ltd. has 21 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 11, 1995
- Date Received
- May 4, 1993
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Perineometer
- Device Class
- Class II
- Regulation Number
- 884.1425
- Review Panel
- GU
- Submission Type
- 510(k)