510(k) DEN990005
DEN990005 is an FDA 510(k) premarket notification submitted by 3pm Co., Inc. for the device "THE 3PM EGG MACHINE". The FDA issued a decision of De Novo Granted on August 20, 1999. The device falls under product code MYE (System, Electrogastrography (Egg)), a Class II device regulated under 21 CFR 876.1735.
Clearance Details
- Decision
- DENG (De Novo Granted)
- Decision Date
- August 20, 1999
- Date Received
- July 12, 1999
- Clearance Type
- Post-NSE
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- System, Electrogastrography (Egg)
- Device Class
- Class II
- Regulation Number
- 876.1735
- Review Panel
- GU
- Submission Type