510(k) K944067
K944067 is an FDA 510(k) premarket notification submitted by Ideal Medical, Inc. for the device "PEANUT WAND, MODIFICATION". The FDA issued a decision of Substantially Equivalent on December 8, 1994. The device falls under product code GCS (Endoscope, Battery-Powered And Accessories), a Class II device regulated under 21 CFR 876.1500. Ideal Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 8, 1994
- Date Received
- July 26, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Endoscope, Battery-Powered And Accessories
- Device Class
- Class II
- Regulation Number
- 876.1500
- Review Panel
- GU
- Submission Type