510(k) K862797
K862797 is an FDA 510(k) premarket notification submitted by Airco, Inc. for the device "AIRCO 2000 SERIES FLOWMETERS". The FDA issued a decision of Substantially Equivalent on August 8, 1986. The device falls under product code CAX (Flowmeter, Tube, Thorpe, Back-Pressure Compensated), a Class I device regulated under 21 CFR 868.2340. Airco, Inc. has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 8, 1986
- Date Received
- July 22, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Flowmeter, Tube, Thorpe, Back-Pressure Compensated
- Device Class
- Class I
- Regulation Number
- 868.2340
- Review Panel
- AN
- Submission Type