510(k) K831698
K831698 is an FDA 510(k) premarket notification submitted by Norton Performance Plastics Corp. for the device "DISPOSABLE PRESSURE TRANSDUCER#14004195". The FDA issued a decision of Substantially Equivalent on August 11, 1983. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. Norton Performance Plastics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 11, 1983
- Date Received
- May 25, 1983
- 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