510(k) K880373
K880373 is an FDA 510(k) premarket notification submitted by Smash Ent., Inc. for the device "IONOMETER E-HK AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on March 17, 1988. The device falls under product code GKF (Instrument, Hematocrit, Automated), a Class II device regulated under 21 CFR 864.5600. Smash Ent., Inc. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 17, 1988
- Date Received
- January 27, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Hematocrit, Automated
- Device Class
- Class II
- Regulation Number
- 864.5600
- Review Panel
- HE
- Submission Type