510(k) K831758
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 19, 1983
- Date Received
- June 1, 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