510(k) K982409
K982409 is an FDA 510(k) premarket notification submitted by Angiolaz, Inc. for the device "VES 1501-M". The FDA issued a decision of Substantially Equivalent on August 21, 1998. The device falls under product code FWF (Camera, Television, Endoscopic, Without Audio), a Class I device regulated under 21 CFR 878.4160. Angiolaz, Inc. has at least 9 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 21, 1998
- Date Received
- July 10, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Camera, Television, Endoscopic, Without Audio
- Device Class
- Class I
- Regulation Number
- 878.4160
- Review Panel
- SU
- Submission Type