510(k) K870811
K870811 is an FDA 510(k) premarket notification submitted by Mesa Medical, Inc. for the device "MODEL 102 PH METER". The FDA issued a decision of Substantially Equivalent on March 24, 1987. The device falls under product code LRI (Ph Meter For Dialysis Hydrogen Ion Concentration), a Class II device regulated under 21 CFR 876.5820. Mesa Medical, Inc. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 24, 1987
- Date Received
- March 3, 1987
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Ph Meter For Dialysis Hydrogen Ion Concentration
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type