510(k) K830680
K830680 is an FDA 510(k) premarket notification submitted by Narco Scientific for the device "AIR-SHIELDS VENTIMETER VENTILATOR-CONTR". The FDA issued a decision of Substantially Equivalent on Apr 8, 1983. The device falls under product code BSZ (Gas-Machine, Anesthesia), a Class II device regulated under 21 CFR 868.5160. Narco Scientific has 29 other 510(k) clearances on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Apr 8, 1983
- Date Received
- Mar 4, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Gas-Machine, Anesthesia
- Device Class
- Class II
- Regulation Number
- 868.5160
- Review Panel
- AN
- Submission Type
- 510(k)