510(k) K902453
K902453 is an FDA 510(k) premarket notification submitted by Thomas J. Fogarty, M.D. for the device "OSCILLOMETRIC PULSE DETECTION DEVICE". The FDA issued a decision of Substantially Equivalent on August 23, 1990. The device falls under product code DRS (Transducer, Blood-Pressure, Extravascular), a Class II device regulated under 21 CFR 870.2850. Thomas J. Fogarty, M.D. has at least 5 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 1990
- Date Received
- June 1, 1990
- 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