510(k) K830898
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- May 16, 1983
- Date Received
- March 21, 1983
- 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