510(k) K850559
K850559 is an FDA 510(k) premarket notification submitted by Precision Medical, Inc. for the device "PRESSURE RELIEF ADAPTOR". The FDA issued a decision of Substantially Equivalent on April 25, 1985. The device falls under product code CAX (Flowmeter, Tube, Thorpe, Back-Pressure Compensated), a Class I device regulated under 21 CFR 868.2340. Precision Medical, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 1985
- Date Received
- February 12, 1985
- 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