510(k) K810290
K810290 is an FDA 510(k) premarket notification submitted by Ohio Medical Products for the device "OHIO CAL-CHEK". The FDA issued a decision of Substantially Equivalent on February 12, 1981. The device falls under product code BXW (Calibrator, Volume, Gas), a Class I device regulated under 21 CFR 868.1870. Ohio Medical Products has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 12, 1981
- Date Received
- February 3, 1981
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Calibrator, Volume, Gas
- Device Class
- Class I
- Regulation Number
- 868.1870
- Review Panel
- AN
- Submission Type