510(k) K863880
K863880 is an FDA 510(k) premarket notification submitted by D.R.G. Scientific Industries for the device "BLOOD GASES/ PO2, PCO2 AND BLOOD PH ANALYSIS PROD.". The FDA issued a decision of Substantially Equivalent on November 24, 1986. The device falls under product code CHL (Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph), a Class II device regulated under 21 CFR 862.1120. D.R.G. Scientific Industries has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 24, 1986
- Date Received
- October 6, 1986
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Electrode Measurement, Blood-Gases (Pco2, Po2) And Blood Ph
- Device Class
- Class II
- Regulation Number
- 862.1120
- Review Panel
- CH
- Submission Type