510(k) K771147
K771147 is an FDA 510(k) premarket notification submitted by Jones Medical Instrument Co. for the device "AVL BLOOD GAS INSTRUMENT MODEL 939". The FDA issued a decision of Substantially Equivalent on Sep 15, 1977. 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. Jones Medical Instrument Co. has 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Sep 15, 1977
- Date Received
- Jun 27, 1977
- 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
- 510(k)