510(k) K802162
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 10, 1980
- Date Received
- September 8, 1980
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Phenolphthalein Colorimetry, Carbon-Dioxide
- Device Class
- Class II
- Regulation Number
- 862.1160
- Review Panel
- CH
- Submission Type