510(k) K023225
K023225 is an FDA 510(k) premarket notification submitted by Puritan Bennett Corp. for the device "PURITAN BENNETT DATAFLOW DATA MANAGEMENT SOFTWARE". The FDA issued a decision of Substantially Equivalent on December 18, 2002. The device falls under product code BZG (Spirometer, Diagnostic), a Class II device regulated under 21 CFR 868.1840. Puritan Bennett Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 2002
- Date Received
- September 27, 2002
- Clearance Type
- Abbreviated
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Spirometer, Diagnostic
- Device Class
- Class II
- Regulation Number
- 868.1840
- Review Panel
- AN
- Submission Type