510(k) K781415
K781415 is an FDA 510(k) premarket notification submitted by Vitalab Products Corp. for the device "CANNULA, NASAL, OXYGEN". The FDA issued a decision of Substantially Equivalent on September 7, 1978. The device falls under product code CAT (Cannula, Nasal, Oxygen), a Class I device regulated under 21 CFR 868.5340. Vitalab Products Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 7, 1978
- Date Received
- August 15, 1978
- 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