510(k) K840522
K840522 is an FDA 510(k) premarket notification submitted by Litton Medical Electronics for the device "RECOMED BLOOD-FLOW METER H236-052-02". The FDA issued a decision of Substantially Equivalent on May 16, 1985. The device falls under product code DPW (Flowmeter, Blood, Cardiovascular), a Class II device regulated under 21 CFR 870.2100. Litton Medical Electronics has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 1985
- Date Received
- February 7, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Flowmeter, Blood, Cardiovascular
- Device Class
- Class II
- Regulation Number
- 870.2100
- Review Panel
- CV
- Submission Type