510(k) K840897
K840897 is an FDA 510(k) premarket notification submitted by Medical Technologies of Georgia for the device "OXYGEN TUBING". The FDA issued a decision of Substantially Equivalent on March 16, 1984. The device falls under product code CAT (Cannula, Nasal, Oxygen), a Class I device regulated under 21 CFR 868.5340. Medical Technologies of Georgia has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 1984
- Date Received
- February 27, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cannula, Nasal, Oxygen
- Device Class
- Class I
- Regulation Number
- 868.5340
- Review Panel
- AN
- Submission Type