510(k) K771150
K771150 is an FDA 510(k) premarket notification submitted by Air Products & Chemicals, Inc. for the device "COPPER KETTLE VAPORIZER PLUS". The FDA issued a decision of Substantially Equivalent on Aug 4, 1977. The device falls under product code CAD (Vaporizer, Anesthesia, Non-Heated), a Class II device regulated under 21 CFR 868.5880. Air Products & Chemicals, Inc. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Aug 4, 1977
- Date Received
- Jun 27, 1977
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Vaporizer, Anesthesia, Non-Heated
- Device Class
- Class II
- Regulation Number
- 868.5880
- Review Panel
- AN
- Submission Type
- 510(k)