510(k) K812883
K812883 is an FDA 510(k) premarket notification submitted by Narco Scientific for the device "TELECARE ISOTEC PRESSURE TRANSDUCER DOME". The FDA issued a decision of Substantially Equivalent on Nov 2, 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
- Nov 2, 1981
- Date Received
- Oct 14, 1981
- 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)