510(k) K120065
K120065 is an FDA 510(k) premarket notification submitted by Plaxtron Industrial (M) Sdn. Bhd. for the device "PLAXTRON SUCTION UNIT, MODEL 88AA51/88AA61 SERIES". The FDA issued a decision of Substantially Equivalent on Apr 3, 2012. The device falls under product code JCX (Apparatus, Suction, Ward Use, Portable, Ac-Powered), a Class II device regulated under 21 CFR 878.4780.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 3, 2012
- Date Received
- Jan 9, 2012
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Suction, Ward Use, Portable, Ac-Powered
- Device Class
- Class II
- Regulation Number
- 878.4780
- Review Panel
- SU
- Submission Type
- 510(k)