510(k) K830910
K830910 is an FDA 510(k) premarket notification submitted by Exco, Inc. for the device "MANOMETER SET C.V.P. #S 298/299". The FDA issued a decision of Substantially Equivalent on April 5, 1983. The device falls under product code KRK (Manometer, Blood-Pressure, Venous), a Class II device regulated under 21 CFR 870.1140. Exco, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 5, 1983
- Date Received
- March 21, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Manometer, Blood-Pressure, Venous
- Device Class
- Class II
- Regulation Number
- 870.1140
- Review Panel
- CV
- Submission Type