Puritan Bennett Dataflow Data Management Software
FDA 510(k) K023225 · Puritan Bennett Corp.
510(k) numberK023225
Submission
- Device name
- Puritan Bennett Dataflow Data Management Software
- Applicant
- Puritan Bennett Corp.
Pleasanton, CA, US - Received
- September 27, 2002
- Decision date
- December 18, 2002
- Decision
- Substantially Equivalent (SESE)
- Type
- Abbreviated 510(k)
- Summary
- 510(k) summary available from FDA
Device classification
- Product code
- BZG – Spirometer, Diagnostic
- Device class
- Class II (moderate risk)
- Regulation
- 21 CFR 868.1840
- Specialty
- Anesthesiology
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Questions and answers
When was Puritan Bennett Dataflow Data Management Software cleared by the FDA?
Puritan Bennett Dataflow Data Management Software (K023225) received a 510(k) decision of Substantially Equivalent on December 18, 2002, 82 days after the submission was received.
What is the product code of K023225?
The FDA product code is BZG – Spirometer, Diagnostic, a Class II (moderate risk) device regulated under 21 CFR 868.1840.