510(k) K873587
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 30, 1987
- Date Received
- September 4, 1987
- 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