510(k) K771246
K771246 is an FDA 510(k) premarket notification submitted by Star Dental Mfg. Co. for the device "ALARM SYS FOR NITROUS OXIDE SYS.". The FDA issued a decision of Substantially Equivalent on July 15, 1977. The device falls under product code ECX (Cylinder, Compressed Gas, And Valve), a Class I device regulated under 21 CFR 868.2700. Star Dental Mfg. Co. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 15, 1977
- Date Received
- July 11, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cylinder, Compressed Gas, And Valve
- Device Class
- Class I
- Regulation Number
- 868.2700
- Review Panel
- AN
- Submission Type