510(k) K897107
K897107 is an FDA 510(k) premarket notification submitted by Cns, Inc. for the device "POLY G PHYSIOLOGICAL DATA RECORDER". The FDA issued a decision of Substantially Equivalent on March 12, 1990. The device falls under product code BXO (Transducer, Gas Pressure), a Class I device regulated under 21 CFR 868.2900. Cns, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 1990
- Date Received
- December 21, 1989
- 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