510(k) K983900
K983900 is an FDA 510(k) premarket notification submitted by Advanced Medical Technology , Ltd. for the device "VENOMETER". The FDA issued a decision of Substantially Equivalent on January 29, 1999. The device falls under product code JOM (Plethysmograph, Photoelectric, Pneumatic Or Hydraulic), a Class II device regulated under 21 CFR 870.2780. Advanced Medical Technology , Ltd. has at least 7 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 29, 1999
- Date Received
- November 3, 1998
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Plethysmograph, Photoelectric, Pneumatic Or Hydraulic
- Device Class
- Class II
- Regulation Number
- 870.2780
- Review Panel
- CV
- Submission Type