510(k) K832897
K832897 is an FDA 510(k) premarket notification submitted by Electromedics, Inc. for the device "MODEL TTPM TIME TEMP. PRESSURE MONITOR". The FDA issued a decision of Substantially Equivalent on March 22, 1984. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. Electromedics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 22, 1984
- Date Received
- August 22, 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