510(k) K822812
K822812 is an FDA 510(k) premarket notification submitted by Yellow Springs Instrument Co., Inc. for the device "YSI MODEL 23L LACTATE ANALYZER". The FDA issued a decision of Substantially Equivalent on December 13, 1982. The device falls under product code HHP (Table, Obstetrical, Manual (And Accessories)), a Class II device regulated under 21 CFR 884.4900. Yellow Springs Instrument Co., Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 13, 1982
- Date Received
- September 20, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Table, Obstetrical, Manual (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.4900
- Review Panel
- OB
- Submission Type