510(k) K080621
K080621 is an FDA 510(k) premarket notification submitted by European Custom Manufacturing BV for the device "FASTLOCK, MODEL PC175M01, PC175MCE, PC005R01". The FDA issued a decision of Substantially Equivalent on April 29, 2008. The device falls under product code DSA (Cable, Transducer And Electrode, Patient, (Including Connector)), a Class II device regulated under 21 CFR 870.2900. European Custom Manufacturing BV has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 29, 2008
- Date Received
- March 5, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cable, Transducer And Electrode, Patient, (Including Connector)
- Device Class
- Class II
- Regulation Number
- 870.2900
- Review Panel
- CV
- Submission Type