510(k) K810314
K810314 is an FDA 510(k) premarket notification submitted by C.R. Bard, Inc. for the device "WILLIAM HARVEY FLOWMETER SYSTEM". The FDA issued a decision of Substantially Equivalent on February 19, 1981. The device falls under product code BYM (Tube, Thorpe, Uncompensated), a Class I device regulated under 21 CFR 868.2320. C.R. Bard, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 19, 1981
- Date Received
- February 5, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tube, Thorpe, Uncompensated
- Device Class
- Class I
- Regulation Number
- 868.2320
- Review Panel
- AN
- Submission Type