510(k) K803096
K803096 is an FDA 510(k) premarket notification submitted by Narco Scientific for the device "NARCO TELECARE TRANSDUCER DOME #700-4000". The FDA issued a decision of Substantially Equivalent on Jan 13, 1981. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. Narco Scientific has 29 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 13, 1981
- Date Received
- Dec 8, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Transducer, Blood-Pressure, Extravascular
- Device Class
- Class II
- Regulation Number
- 870.2850
- Review Panel
- CV
- Submission Type
- 510(k)