510(k) K013091
K013091 is an FDA 510(k) premarket notification submitted by Von Zeppelin GmbH for the device "ZMM 2000 ZEPPELIN MILLENNIUM MOTORDRILL SYSTEM". The FDA issued a decision of Substantially Equivalent on January 25, 2002. The device falls under product code HBB (Motor, Drill, Pneumatic), a Class II device regulated under 21 CFR 882.4370. Von Zeppelin GmbH has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 25, 2002
- Date Received
- September 17, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Motor, Drill, Pneumatic
- Device Class
- Class II
- Regulation Number
- 882.4370
- Review Panel
- NE
- Submission Type