510(k) K944027
K944027 is an FDA 510(k) premarket notification submitted by Nihon Kohden America, Inc. for the device "AG-839PA CO2 MODULE AND ACCESSORIES". The FDA issued a decision of Substantially Equivalent on August 31, 1994. The device falls under product code BXO (Transducer, Gas Pressure), a Class I device regulated under 21 CFR 868.2900. Nihon Kohden America, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 31, 1994
- Date Received
- August 17, 1994
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Transducer, Gas Pressure
- Device Class
- Class I
- Regulation Number
- 868.2900
- Review Panel
- AN
- Submission Type