510(k) K781386
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 14, 1978
- Date Received
- August 11, 1978
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tonometer (Calibration And Q.C. Of Blood-Gas Instruments), Clinical
- Device Class
- Class I
- Regulation Number
- 862.1660
- Review Panel
- CH
- Submission Type