510(k) K802591
K802591 is an FDA 510(k) premarket notification submitted by G. Dundas Co. for the device "MODEL 5460 + 5480 POP-OFF VALVES". The FDA issued a decision of Substantially Equivalent on November 12, 1980. The device falls under product code BSZ (Gas-Machine, Anesthesia), a Class II device regulated under 21 CFR 868.5160. G. Dundas Co. has at least 1 other 510(k) clearance on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 12, 1980
- Date Received
- October 21, 1980
- 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