510(k) K942866
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 1, 1994
- Date Received
- June 17, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gas, Calibration (Specified Concentration)
- Device Class
- Class I
- Regulation Number
- 868.6400
- Review Panel
- AN
- Submission Type